NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m² at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m² or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.

Indeed, patients with a baseline BMI of 40 kg/m² or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m² 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.

“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m². And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m² 1 year post surgery had a preoperative BMI of 40 kg/m² or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m² or below.

Among patients with a preoperative BMI of 50-59 kg/m², only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m², only 0.4% had a BMI of less than 30 kg/m² at 1 year.

“Patients with a BMI of 50 kg/m² or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.

Why is a postsurgical BMI below 30 kg/m² such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m² or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.

In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.

The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.

Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.

Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m² at 1 year and those who did not.
 

Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.

Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m² in 2006 and 46.9 kg/m² in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m², respectively, in those years.

Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m² before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.

Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.

“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.

Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
 

[email protected]

NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m² at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m² or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.

Indeed, patients with a baseline BMI of 40 kg/m² or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m² 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.

“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m². And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m² 1 year post surgery had a preoperative BMI of 40 kg/m² or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m² or below.

Among patients with a preoperative BMI of 50-59 kg/m², only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m², only 0.4% had a BMI of less than 30 kg/m² at 1 year.

“Patients with a BMI of 50 kg/m² or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.

Why is a postsurgical BMI below 30 kg/m² such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m² or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.

In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.

The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.

Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.

Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m² at 1 year and those who did not.
 

Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.

Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m² in 2006 and 46.9 kg/m² in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m², respectively, in those years.

Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m² before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.

Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.

“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.

Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
 

[email protected]

NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m² at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m² or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.

Indeed, patients with a baseline BMI of 40 kg/m² or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m² 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.

“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m². And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m² 1 year post surgery had a preoperative BMI of 40 kg/m² or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m² or below.

Among patients with a preoperative BMI of 50-59 kg/m², only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m², only 0.4% had a BMI of less than 30 kg/m² at 1 year.

“Patients with a BMI of 50 kg/m² or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.

Why is a postsurgical BMI below 30 kg/m² such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m² or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.

In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.

The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.

Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.

Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m² at 1 year and those who did not.
 

Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.

Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m² in 2006 and 46.9 kg/m² in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m², respectively, in those years.

Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m² before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.

Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.

“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.

Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
 

[email protected]

In the final of a three-part series about developing and implementing a quality improvement initiative, Dr. Bernstein and his colleagues outline how such a program can be sustained and cemented into a gastroenterology practice. This mini-series has focused on community practices and presented a road map for quality improvement through descriptions of clinical vignettes – specifically focused on improving adenoma detection rates. In multiple other articles within the Toolbox series, we have described how gastroenterologists can measure and improve one of our most important outcome measures – the adenoma detection rate for screening colonoscopy. We all are aware of the Hawthorne effect (that is, observer effect) in which people modify their behavior in response to being measured or observed. The key to sustained quality improvement is to change fundamental practices once the flush of initial success fades.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

Series review

In this series, you are a community-based urban general gastroenterologist asked by hospital administration to improve your current group adenoma detection rate (ADR) of 19% to the established target of 25% among each individual endoscopist within the group during a 12-month period.

The team has implemented standardized endoscopist report cards during the past 9 months. At present, ADR has been more than 25% for all practitioners for 4 consecutive months. The quality improvement team meets to determine how to sustain the gains long term.

Sustainability of improved outcomes has been defined as: “When new ways of working and improved outcomes become the norm.”¹ This incorporates a number of important concepts. “New ways of working” means that a change has been made in the way care has been provided. This includes interventions such as a new policy, implementation of a checklist, or a new clinical pathway. “Improved outcomes” implies that the result of the intervention has been measured and has demonstrated an improvement. “Become the norm” means that this change has now become a part of standard work and does not need ongoing support to continue.

Although a great deal of literature currently exists that focuses on initiation and implementation of quality improvement (QI) activities, much less has been written on sustaining efforts once the goal has been achieved. A number of reasons have been proposed for this, including stability being typically regarded as less interesting, as well as the research requiring much longer time frames for study.² However, there is important evidence that suggests that up to 70% of long-term changes in health care organizations ultimately fail.³ This indicates a pressing need for effective strategies to sustain improved outcomes.

Challenges

A number of challenges face the sustainability phase of an intervention.² First, the initial enthusiasm for a novel intervention wanes after time, often limiting long-term compliance if it has not become part of standard work. Second, the local or national support for a project may have changed as strategic priorities shift. This can result in a loss of leadership support and/or resources. Third, most institutions value novel ideas over a steady state, and focusing on the next initiative offers more career value for managers as compared with maintaining current practices. Finally, it is common for groups to declare victory too soon. This is defined as celebrating the first performance improvement as the final goal instead of it being the first step to long-term success.

Determining readiness for sustainability

The first step in determining readiness for sustaining an improvement is to determine whether there has been an actual improvement to sustain. This means both completing the plan-do-study-act cycles and establishing a true steady state. In addition, it needs to be demonstrated that a sustained change has occurred. The second article in this series addresses these steps in detail.⁴

The National Health Service (United Kingdom) Improvement Leaders’ Guide to Sustainability and Spread identifies four sets of questions to ask when determining whether a project can enter the sustainability phase.³

1. Is the (intervention) near the final stage of development? If there were room for further changes, would these completely alter the way the solution has been introduced?

2. Are the measurements demonstrating real improvement?

3. Who cares about this improvement? Is the solution representative of the wider views of those involved?

4. What policy or technological changes may render this solution redundant? When might this happen?

Once the answers to these questions have been determined and it is believed that a steady state has been achieved, it is time to move on to sustaining the intervention. Article no. 2 in our series outlines how to know whether an improvement has occurred. Although there is no single metric that can determine a project is in a steady state, it is generally believed that four or five cycles with consistent improvement and without special cause variation, along with an intervention that has been fully established, typically represent a steady state.

ACTION PLAN: For the ADR example, the answers to the questions are as follows:

1. The intervention was developed and finalized through iterative design among the QI team.

2. Performance has been consistently above target among all endoscopists for 4 consecutive months.

3. ADR is an important quality metric to individual endoscopists as well as hospital leadership. Moreover, because there are increasing models tying reimbursement to funding that are based on adherence to quality indicators, ADR will become more important.

4. If hospitals become mandated to provide scorecard data, the intervention may become redundant. However, the measurement and implications of the data still may be relevant to ongoing QI activities.

Interventions supporting sustainability

Sustainability planning is ideally started at the initiation phase of the project. When choosing a target for change, consideration of organizational factors such as strategic priorities, staff engagement, and leadership support are integral to long-term success. Factors influencing the type of intervention developed should include available funding (both long term and short term), existing information technology (IT) resources, and the ability to incorporate into existing workflow. Considering these factors from the outset will help improve a project’s long-term viability.

A number of toolkits have been produced to guide QI teams through the sustainability process. The National Health Service Institute for Innovation and Improvement has produced a comprehensive guide to sustainability.⁴ The guide provides advice on how to identify opportunities to increase the likelihood of sustainability for your initiative. It is accompanied by a model that can be used to predict success by dividing the factors influencing sustainability into three groups: staff, process, and organization. Each of these has a number of subcategories, and relative significance is attributed to each, with staff factors (clinical leadership engagement, senior leadership engagement, staff involvement in the change, and staff attitudes toward the change) holding the highest weighting. On the basis of the results of the model, the QI team can identify both the likelihood of success as well as opportunities for improvement.

Visual aids are another intervention that promotes sustainability. Visual cues such as posters, buttons, and magnets act as easy reminders for front-line staff. Creating a storyboard at the beginning of the project allows stakeholders to have a broad perspective on both the intervention and sustainability phases.⁵ Ongoing auditing and reporting of results also encourage long-term compliance. This can take the form of posting results of the intervention in the department on a regular basis as well as reports to senior administration. Regular check-ins with all stakeholders are also encouraged. This can be at a monthly staff meeting or a brief “improvement huddle” on a standing basis.

Factors influencing success

Any discussion of QI work must consider context. An understanding of the system one is working within will allow for optimization of system strengths and avoidance of pitfalls because of weaknesses. A lack of attention to context can lead to an unsuccessful project. This could be due to choosing a focus that is not in line with hospital priorities, a project that is asking staff to take on additional tasks without removing others, or developing a solution that requires funding or IT infrastructure that is not readily available.

Any organization has a number of different settings that need to be considered simultaneously. This is most simply divided into microsystem, mesosystem, and macrosystem. Microsystem is defined as the combination of a small team of people who work together on a regular basis. The mesosystem focuses on the integrated care needs of a particular group or population with the same diseases or conditions and provides support for individual microsystems. The macrosystem forms the infrastructure of the larger organization, providing the systems and governance that define the system.⁶ In our example, the microsystem is the endoscopy unit, including physicians, nurses, administrative support, and managers. The mesosystem is composed of the endoscopy unit in addition to the Departments of Gastroenterology and Surgery, the hospital IT team, and the Pathology Department. The macrosystem is the hospital, including senior leadership and administration. Another way of thinking about this is the microsystem is the environment most easily influenced by the individual provider, whereas the macrosystem includes the organizational-level factors that need to be taken into consideration when designing an intervention.

A great number of factors have been proposed to influence sustainability. National Health Service Scotland performed a literature review and met with subject matter experts to determine key factors that require consideration when engaging in activities to sustain and spread QI activities. They produced a guide that focused on 10 factors thought to have the greatest influence.⁶ Although a review of all 10 factors is beyond the scope of this review, we will highlight key ones to consider.

Innovation

The nature of the change greatly influences its likelihood of being sustained. In addition, one must consider the process of the intervention as well as those who will be impacted by the change. Core qualities that predispose to success include the following:⁷

1. Clear advantage compared with current ways

2. Compatibility/integration with current systems and values

3. Simplicity of the change and its implementation

4. Ease of testing

5. Observability of the change and its impact

This list highlights the point that the plan to sustain an intervention needs to start at the design phase and not once the change has been proven successful. Support among users also influences long-term success. Early adopters are those who embrace the intervention or change. Identifying the early adopters and using their support for positive publicity and momentum are integral in any sustainability effort.

ACTION PLAN: In our example, components of the intervention that would predispose to sustainability include choosing an outcome that is aligned with the hospital’s strategic focus (for example, cancer screening and prevention). ADR is already a measurable outcome at the hospital, which facilitates dissemination of results. Alternatively, some of the resistance to change may be due to the increased work to compile and distribute the scorecards monthly.

Organizational culture

Culture has been most simply defined as “the way we do things around here”.⁷ The approach of an organization toward QI will clearly impact its long-term viability. On a macrosystem level, interventions should ideally fit within strategic goals and priorities of organizations to garner maximum support. When promoting the intervention, it may be appropriate to focus on the benefits to the individual group (that is, cost savings to senior administration, time saved to front-line staff). Studies have shown that teams that demonstrate a strong teamwork ethic, have a positive attitude toward the intervention, and where all members know and understand their role on the team were more likely to have sustained success.⁸ In addition, engagement of all key stakeholders early in the process has been correlated with improved long-term outcomes. In a microsystem level, providers can choose to implement the intervention among a well-established team that works well together, ideally where there is a history or prior QI work.

Factors that may make sustaining a QI effort more challenging include interventions that increase time or costs to the organization. Many healthcare organizations may have specific targets set out from their regulatory body. If the intervention lowers the result of one of the targeted outcomes (or does not address those targets at all), it may be met with increased resistance within a system. In cases like this it is integral to use data to demonstrate to senior leadership why this still has tangible benefit to the organization.

ACTION PLAN: In our example, culture can promote sustainability on a microsystem level through reinforcing local success stories. This can be through posting of visual aids in the unit such as posters that display performance or progress boards that chart the status of the intervention. In addition, QI projects can be a regular agenda item at unit meetings, reinforcing their importance to team members.

Leadership

One key component of organizational culture is the influence of leadership. An effective leader will have both technical QI skills and strong interpersonal skills.⁷ Teams where all members feel comfortable making suggestions or voicing concerns are far more likely to succeed, and it is incumbent on leadership to create this environment. This concept is often termed psychological safety and has been directly linked to the inclusiveness of the leader. Team members with psychological safety are more likely to feel like active participants in the process, and this improves their long-term engagement.^7,8 In addition, effective leaders create accountability systems to ensure gains are maintained. These may include regular performance reviews, reminders about the intervention, and assigning responsibility to senior level team members. Finally, celebration of accomplishments reinforces the positive impact of the time and energy invested by members of the team.⁹ The concept of distributed leadership is another key concept. This acknowledges that for any one intervention, there are a number of formal and informal leadership roles, and these can be filled by a number of different individuals.⁷

ACTION PLAN: For our ADR example, sustainability can be promoted through effective leadership. On a microsystem level, one option is the implementation of a weekly Improvement Huddle. This is a 10- to 15-minute meeting within the microsystem that is designed to review current performance and anticipate problems. All team members are encouraged to voice any concerns. On the macrosystem level, quarterly reports to senior administration and presentation of process and results at Grand Rounds may contribute to this goal.

Change management

Change management looks at how an organization approaches the new ways of working. This can be on both a social level and a technical level (often termed Organizational Infrastructure). Creating interventions that integrate with existing systems (data collection, workflow) is ideal for sustainability because it can serve to reinforce the change as standard work. In instances where the change does not immediately integrate, organizations can support change by demonstrating flexibility. This includes modification of existing technology to measure the desired outcome, development of new protocols to integrate the modified workflow, or changing job definitions of team members to demonstrate that the intervention is now considered part of daily responsibilities. Ongoing feedback also reinforces maintenance of performance. This can be through performance reviews for staff members as well as providing data to the appropriate audiences to demonstrate sustained gains.^7,9

ACTION PLAN: For the ADR example, change management can contribute to sustainability through creation of a sustainable data reporting system that integrates current workflow. This will allow ongoing measurement of key metrics and is integral for long-term viability.

Summary

In this final article of a three-part series directed toward gastroenterologists interested in local QI endeavors, we selectively reviewed concepts surrounding sustainability of QI endeavors. This included determining readiness and understanding the factors that influence long-term success on both a macrosystem and microsystem level. Factors under the direct control of the individual practitioner were highlighted to give examples of specific strategies for successful sustainability.

References

1. Thomas, S., Zahn, D. Sustaining improved outcomes: a toolkit. Available at: http://nyshealthfoundation.org/resources-and-reports/resource/sustaining-improved-outcomes-a-toolkit.

2. Buchanan, D., Fitzgerald, L., Ketley, D., et al. No going back: a review of the literature on sustaining organizational change. Int. J Manag Rev. 2005;7:189-205.

3. Sustainability: model and guide. National Health Service Institute for Innovation and Improvement, Leeds, U.K.; 2007.

4. Improvement leaders’ guide to sustainability and spread. NHS Modernisation Agency. Ipswich, England: Ancient House Printing Group; 2002.

5. Nelson, E.C., Batalden, P.B., Godfrey, M.M. Quality by design: a clinical microsystems approach. Jossey-Bass, San Francisco, Calif; 2007.

6. Available at: http://www.ashpfoundation.org/lean.

7. NHS Scotland Quality Improvement Hub. The spread and sustainability of quality improvement in healthcare. 2014. Available at: http://www.qihub.scot.nhs.uk/knowledge-centre/quality-improvement-topics/spread-and-sustainability.aspx.

8. Healthcare Improvement Scotland. Quality improvement: sustainable in any organizational culture? 2013. Available at: http://www.healthcareimprovementscotland.org/previous_resources/benchmarking_report/quality_improvement_report.aspx.

9. 5 Million Lives Campaign. Getting started kit: rapid response teams. Institute for Healthcare Improvement, Cambridge, MA; 2008 (Available at:) www.ihi.org.
 

Dr. Bernstein is in the division of gastroenterology, department of medicine, Sunnybrook Health Sciences Centre; Dr. Weizman is at the Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine, and Institute of Health Policy, Management and Evaluation; Dr. Mosko is in the division of gastroenterology, department of medicine, St. Michael’s Hospital, and the Institute of Health Policy, Management, and Evaluation; Dr. Bollegala is in the division of gastroenterology, department of medicine, Women’s College Hospital; Dr. Brahmania is in the Toronto Center for Liver Diseases, division of gastroenterology, department of medicine, University Health Network; Dr. Liu is in the division of gastroenterology, department of medicine, University Health Network; Dr. Steinhart is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine and Institute of Health Policy, Management, and Evaluation; Dr. Silver is in the division of nephrology, St. Michael’s Hospital; Dr. Nguyen is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine; and Dr. Bell is in the division of internal medicine, department of medicine, Mount Sinai Hospital. All are at the University of Toronto except Dr. Hou, who is at the Houston VA Health Services Research and Development Center of Excellence, Michael DeBakey Veterans Affairs Medical Center, and the section of gastroenterology and hepatology, Baylor College of Medicine, Houston. The authors disclose no conflicts.

In the final of a three-part series about developing and implementing a quality improvement initiative, Dr. Bernstein and his colleagues outline how such a program can be sustained and cemented into a gastroenterology practice. This mini-series has focused on community practices and presented a road map for quality improvement through descriptions of clinical vignettes – specifically focused on improving adenoma detection rates. In multiple other articles within the Toolbox series, we have described how gastroenterologists can measure and improve one of our most important outcome measures – the adenoma detection rate for screening colonoscopy. We all are aware of the Hawthorne effect (that is, observer effect) in which people modify their behavior in response to being measured or observed. The key to sustained quality improvement is to change fundamental practices once the flush of initial success fades.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

Series review

In this series, you are a community-based urban general gastroenterologist asked by hospital administration to improve your current group adenoma detection rate (ADR) of 19% to the established target of 25% among each individual endoscopist within the group during a 12-month period.

The team has implemented standardized endoscopist report cards during the past 9 months. At present, ADR has been more than 25% for all practitioners for 4 consecutive months. The quality improvement team meets to determine how to sustain the gains long term.

Sustainability of improved outcomes has been defined as: “When new ways of working and improved outcomes become the norm.”¹ This incorporates a number of important concepts. “New ways of working” means that a change has been made in the way care has been provided. This includes interventions such as a new policy, implementation of a checklist, or a new clinical pathway. “Improved outcomes” implies that the result of the intervention has been measured and has demonstrated an improvement. “Become the norm” means that this change has now become a part of standard work and does not need ongoing support to continue.

Although a great deal of literature currently exists that focuses on initiation and implementation of quality improvement (QI) activities, much less has been written on sustaining efforts once the goal has been achieved. A number of reasons have been proposed for this, including stability being typically regarded as less interesting, as well as the research requiring much longer time frames for study.² However, there is important evidence that suggests that up to 70% of long-term changes in health care organizations ultimately fail.³ This indicates a pressing need for effective strategies to sustain improved outcomes.

Challenges

A number of challenges face the sustainability phase of an intervention.² First, the initial enthusiasm for a novel intervention wanes after time, often limiting long-term compliance if it has not become part of standard work. Second, the local or national support for a project may have changed as strategic priorities shift. This can result in a loss of leadership support and/or resources. Third, most institutions value novel ideas over a steady state, and focusing on the next initiative offers more career value for managers as compared with maintaining current practices. Finally, it is common for groups to declare victory too soon. This is defined as celebrating the first performance improvement as the final goal instead of it being the first step to long-term success.

Determining readiness for sustainability

The first step in determining readiness for sustaining an improvement is to determine whether there has been an actual improvement to sustain. This means both completing the plan-do-study-act cycles and establishing a true steady state. In addition, it needs to be demonstrated that a sustained change has occurred. The second article in this series addresses these steps in detail.⁴

The National Health Service (United Kingdom) Improvement Leaders’ Guide to Sustainability and Spread identifies four sets of questions to ask when determining whether a project can enter the sustainability phase.³

1. Is the (intervention) near the final stage of development? If there were room for further changes, would these completely alter the way the solution has been introduced?

2. Are the measurements demonstrating real improvement?

3. Who cares about this improvement? Is the solution representative of the wider views of those involved?

4. What policy or technological changes may render this solution redundant? When might this happen?

Once the answers to these questions have been determined and it is believed that a steady state has been achieved, it is time to move on to sustaining the intervention. Article no. 2 in our series outlines how to know whether an improvement has occurred. Although there is no single metric that can determine a project is in a steady state, it is generally believed that four or five cycles with consistent improvement and without special cause variation, along with an intervention that has been fully established, typically represent a steady state.

ACTION PLAN: For the ADR example, the answers to the questions are as follows:

1. The intervention was developed and finalized through iterative design among the QI team.

2. Performance has been consistently above target among all endoscopists for 4 consecutive months.

3. ADR is an important quality metric to individual endoscopists as well as hospital leadership. Moreover, because there are increasing models tying reimbursement to funding that are based on adherence to quality indicators, ADR will become more important.

4. If hospitals become mandated to provide scorecard data, the intervention may become redundant. However, the measurement and implications of the data still may be relevant to ongoing QI activities.

Interventions supporting sustainability

Sustainability planning is ideally started at the initiation phase of the project. When choosing a target for change, consideration of organizational factors such as strategic priorities, staff engagement, and leadership support are integral to long-term success. Factors influencing the type of intervention developed should include available funding (both long term and short term), existing information technology (IT) resources, and the ability to incorporate into existing workflow. Considering these factors from the outset will help improve a project’s long-term viability.

A number of toolkits have been produced to guide QI teams through the sustainability process. The National Health Service Institute for Innovation and Improvement has produced a comprehensive guide to sustainability.⁴ The guide provides advice on how to identify opportunities to increase the likelihood of sustainability for your initiative. It is accompanied by a model that can be used to predict success by dividing the factors influencing sustainability into three groups: staff, process, and organization. Each of these has a number of subcategories, and relative significance is attributed to each, with staff factors (clinical leadership engagement, senior leadership engagement, staff involvement in the change, and staff attitudes toward the change) holding the highest weighting. On the basis of the results of the model, the QI team can identify both the likelihood of success as well as opportunities for improvement.

Visual aids are another intervention that promotes sustainability. Visual cues such as posters, buttons, and magnets act as easy reminders for front-line staff. Creating a storyboard at the beginning of the project allows stakeholders to have a broad perspective on both the intervention and sustainability phases.⁵ Ongoing auditing and reporting of results also encourage long-term compliance. This can take the form of posting results of the intervention in the department on a regular basis as well as reports to senior administration. Regular check-ins with all stakeholders are also encouraged. This can be at a monthly staff meeting or a brief “improvement huddle” on a standing basis.

Factors influencing success

Any discussion of QI work must consider context. An understanding of the system one is working within will allow for optimization of system strengths and avoidance of pitfalls because of weaknesses. A lack of attention to context can lead to an unsuccessful project. This could be due to choosing a focus that is not in line with hospital priorities, a project that is asking staff to take on additional tasks without removing others, or developing a solution that requires funding or IT infrastructure that is not readily available.

Any organization has a number of different settings that need to be considered simultaneously. This is most simply divided into microsystem, mesosystem, and macrosystem. Microsystem is defined as the combination of a small team of people who work together on a regular basis. The mesosystem focuses on the integrated care needs of a particular group or population with the same diseases or conditions and provides support for individual microsystems. The macrosystem forms the infrastructure of the larger organization, providing the systems and governance that define the system.⁶ In our example, the microsystem is the endoscopy unit, including physicians, nurses, administrative support, and managers. The mesosystem is composed of the endoscopy unit in addition to the Departments of Gastroenterology and Surgery, the hospital IT team, and the Pathology Department. The macrosystem is the hospital, including senior leadership and administration. Another way of thinking about this is the microsystem is the environment most easily influenced by the individual provider, whereas the macrosystem includes the organizational-level factors that need to be taken into consideration when designing an intervention.

A great number of factors have been proposed to influence sustainability. National Health Service Scotland performed a literature review and met with subject matter experts to determine key factors that require consideration when engaging in activities to sustain and spread QI activities. They produced a guide that focused on 10 factors thought to have the greatest influence.⁶ Although a review of all 10 factors is beyond the scope of this review, we will highlight key ones to consider.

Innovation

The nature of the change greatly influences its likelihood of being sustained. In addition, one must consider the process of the intervention as well as those who will be impacted by the change. Core qualities that predispose to success include the following:⁷

1. Clear advantage compared with current ways

2. Compatibility/integration with current systems and values

3. Simplicity of the change and its implementation

4. Ease of testing

5. Observability of the change and its impact

This list highlights the point that the plan to sustain an intervention needs to start at the design phase and not once the change has been proven successful. Support among users also influences long-term success. Early adopters are those who embrace the intervention or change. Identifying the early adopters and using their support for positive publicity and momentum are integral in any sustainability effort.

ACTION PLAN: In our example, components of the intervention that would predispose to sustainability include choosing an outcome that is aligned with the hospital’s strategic focus (for example, cancer screening and prevention). ADR is already a measurable outcome at the hospital, which facilitates dissemination of results. Alternatively, some of the resistance to change may be due to the increased work to compile and distribute the scorecards monthly.

Organizational culture

Culture has been most simply defined as “the way we do things around here”.⁷ The approach of an organization toward QI will clearly impact its long-term viability. On a macrosystem level, interventions should ideally fit within strategic goals and priorities of organizations to garner maximum support. When promoting the intervention, it may be appropriate to focus on the benefits to the individual group (that is, cost savings to senior administration, time saved to front-line staff). Studies have shown that teams that demonstrate a strong teamwork ethic, have a positive attitude toward the intervention, and where all members know and understand their role on the team were more likely to have sustained success.⁸ In addition, engagement of all key stakeholders early in the process has been correlated with improved long-term outcomes. In a microsystem level, providers can choose to implement the intervention among a well-established team that works well together, ideally where there is a history or prior QI work.

Factors that may make sustaining a QI effort more challenging include interventions that increase time or costs to the organization. Many healthcare organizations may have specific targets set out from their regulatory body. If the intervention lowers the result of one of the targeted outcomes (or does not address those targets at all), it may be met with increased resistance within a system. In cases like this it is integral to use data to demonstrate to senior leadership why this still has tangible benefit to the organization.

ACTION PLAN: In our example, culture can promote sustainability on a microsystem level through reinforcing local success stories. This can be through posting of visual aids in the unit such as posters that display performance or progress boards that chart the status of the intervention. In addition, QI projects can be a regular agenda item at unit meetings, reinforcing their importance to team members.

Leadership

One key component of organizational culture is the influence of leadership. An effective leader will have both technical QI skills and strong interpersonal skills.⁷ Teams where all members feel comfortable making suggestions or voicing concerns are far more likely to succeed, and it is incumbent on leadership to create this environment. This concept is often termed psychological safety and has been directly linked to the inclusiveness of the leader. Team members with psychological safety are more likely to feel like active participants in the process, and this improves their long-term engagement.^7,8 In addition, effective leaders create accountability systems to ensure gains are maintained. These may include regular performance reviews, reminders about the intervention, and assigning responsibility to senior level team members. Finally, celebration of accomplishments reinforces the positive impact of the time and energy invested by members of the team.⁹ The concept of distributed leadership is another key concept. This acknowledges that for any one intervention, there are a number of formal and informal leadership roles, and these can be filled by a number of different individuals.⁷

ACTION PLAN: For our ADR example, sustainability can be promoted through effective leadership. On a microsystem level, one option is the implementation of a weekly Improvement Huddle. This is a 10- to 15-minute meeting within the microsystem that is designed to review current performance and anticipate problems. All team members are encouraged to voice any concerns. On the macrosystem level, quarterly reports to senior administration and presentation of process and results at Grand Rounds may contribute to this goal.

Change management

Change management looks at how an organization approaches the new ways of working. This can be on both a social level and a technical level (often termed Organizational Infrastructure). Creating interventions that integrate with existing systems (data collection, workflow) is ideal for sustainability because it can serve to reinforce the change as standard work. In instances where the change does not immediately integrate, organizations can support change by demonstrating flexibility. This includes modification of existing technology to measure the desired outcome, development of new protocols to integrate the modified workflow, or changing job definitions of team members to demonstrate that the intervention is now considered part of daily responsibilities. Ongoing feedback also reinforces maintenance of performance. This can be through performance reviews for staff members as well as providing data to the appropriate audiences to demonstrate sustained gains.^7,9

ACTION PLAN: For the ADR example, change management can contribute to sustainability through creation of a sustainable data reporting system that integrates current workflow. This will allow ongoing measurement of key metrics and is integral for long-term viability.

Summary

In this final article of a three-part series directed toward gastroenterologists interested in local QI endeavors, we selectively reviewed concepts surrounding sustainability of QI endeavors. This included determining readiness and understanding the factors that influence long-term success on both a macrosystem and microsystem level. Factors under the direct control of the individual practitioner were highlighted to give examples of specific strategies for successful sustainability.

References

1. Thomas, S., Zahn, D. Sustaining improved outcomes: a toolkit. Available at: http://nyshealthfoundation.org/resources-and-reports/resource/sustaining-improved-outcomes-a-toolkit.

2. Buchanan, D., Fitzgerald, L., Ketley, D., et al. No going back: a review of the literature on sustaining organizational change. Int. J Manag Rev. 2005;7:189-205.

3. Sustainability: model and guide. National Health Service Institute for Innovation and Improvement, Leeds, U.K.; 2007.

4. Improvement leaders’ guide to sustainability and spread. NHS Modernisation Agency. Ipswich, England: Ancient House Printing Group; 2002.

5. Nelson, E.C., Batalden, P.B., Godfrey, M.M. Quality by design: a clinical microsystems approach. Jossey-Bass, San Francisco, Calif; 2007.

6. Available at: http://www.ashpfoundation.org/lean.

7. NHS Scotland Quality Improvement Hub. The spread and sustainability of quality improvement in healthcare. 2014. Available at: http://www.qihub.scot.nhs.uk/knowledge-centre/quality-improvement-topics/spread-and-sustainability.aspx.

8. Healthcare Improvement Scotland. Quality improvement: sustainable in any organizational culture? 2013. Available at: http://www.healthcareimprovementscotland.org/previous_resources/benchmarking_report/quality_improvement_report.aspx.

9. 5 Million Lives Campaign. Getting started kit: rapid response teams. Institute for Healthcare Improvement, Cambridge, MA; 2008 (Available at:) www.ihi.org.
 

Dr. Bernstein is in the division of gastroenterology, department of medicine, Sunnybrook Health Sciences Centre; Dr. Weizman is at the Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine, and Institute of Health Policy, Management and Evaluation; Dr. Mosko is in the division of gastroenterology, department of medicine, St. Michael’s Hospital, and the Institute of Health Policy, Management, and Evaluation; Dr. Bollegala is in the division of gastroenterology, department of medicine, Women’s College Hospital; Dr. Brahmania is in the Toronto Center for Liver Diseases, division of gastroenterology, department of medicine, University Health Network; Dr. Liu is in the division of gastroenterology, department of medicine, University Health Network; Dr. Steinhart is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine and Institute of Health Policy, Management, and Evaluation; Dr. Silver is in the division of nephrology, St. Michael’s Hospital; Dr. Nguyen is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine; and Dr. Bell is in the division of internal medicine, department of medicine, Mount Sinai Hospital. All are at the University of Toronto except Dr. Hou, who is at the Houston VA Health Services Research and Development Center of Excellence, Michael DeBakey Veterans Affairs Medical Center, and the section of gastroenterology and hepatology, Baylor College of Medicine, Houston. The authors disclose no conflicts.

In the final of a three-part series about developing and implementing a quality improvement initiative, Dr. Bernstein and his colleagues outline how such a program can be sustained and cemented into a gastroenterology practice. This mini-series has focused on community practices and presented a road map for quality improvement through descriptions of clinical vignettes – specifically focused on improving adenoma detection rates. In multiple other articles within the Toolbox series, we have described how gastroenterologists can measure and improve one of our most important outcome measures – the adenoma detection rate for screening colonoscopy. We all are aware of the Hawthorne effect (that is, observer effect) in which people modify their behavior in response to being measured or observed. The key to sustained quality improvement is to change fundamental practices once the flush of initial success fades.
 

John I. Allen, MD, MBA, AGAF

Editor in Chief

Series review

In this series, you are a community-based urban general gastroenterologist asked by hospital administration to improve your current group adenoma detection rate (ADR) of 19% to the established target of 25% among each individual endoscopist within the group during a 12-month period.

The team has implemented standardized endoscopist report cards during the past 9 months. At present, ADR has been more than 25% for all practitioners for 4 consecutive months. The quality improvement team meets to determine how to sustain the gains long term.

Sustainability of improved outcomes has been defined as: “When new ways of working and improved outcomes become the norm.”¹ This incorporates a number of important concepts. “New ways of working” means that a change has been made in the way care has been provided. This includes interventions such as a new policy, implementation of a checklist, or a new clinical pathway. “Improved outcomes” implies that the result of the intervention has been measured and has demonstrated an improvement. “Become the norm” means that this change has now become a part of standard work and does not need ongoing support to continue.

Although a great deal of literature currently exists that focuses on initiation and implementation of quality improvement (QI) activities, much less has been written on sustaining efforts once the goal has been achieved. A number of reasons have been proposed for this, including stability being typically regarded as less interesting, as well as the research requiring much longer time frames for study.² However, there is important evidence that suggests that up to 70% of long-term changes in health care organizations ultimately fail.³ This indicates a pressing need for effective strategies to sustain improved outcomes.

Challenges

A number of challenges face the sustainability phase of an intervention.² First, the initial enthusiasm for a novel intervention wanes after time, often limiting long-term compliance if it has not become part of standard work. Second, the local or national support for a project may have changed as strategic priorities shift. This can result in a loss of leadership support and/or resources. Third, most institutions value novel ideas over a steady state, and focusing on the next initiative offers more career value for managers as compared with maintaining current practices. Finally, it is common for groups to declare victory too soon. This is defined as celebrating the first performance improvement as the final goal instead of it being the first step to long-term success.

Determining readiness for sustainability

The first step in determining readiness for sustaining an improvement is to determine whether there has been an actual improvement to sustain. This means both completing the plan-do-study-act cycles and establishing a true steady state. In addition, it needs to be demonstrated that a sustained change has occurred. The second article in this series addresses these steps in detail.⁴

The National Health Service (United Kingdom) Improvement Leaders’ Guide to Sustainability and Spread identifies four sets of questions to ask when determining whether a project can enter the sustainability phase.³

1. Is the (intervention) near the final stage of development? If there were room for further changes, would these completely alter the way the solution has been introduced?

2. Are the measurements demonstrating real improvement?

3. Who cares about this improvement? Is the solution representative of the wider views of those involved?

4. What policy or technological changes may render this solution redundant? When might this happen?

Once the answers to these questions have been determined and it is believed that a steady state has been achieved, it is time to move on to sustaining the intervention. Article no. 2 in our series outlines how to know whether an improvement has occurred. Although there is no single metric that can determine a project is in a steady state, it is generally believed that four or five cycles with consistent improvement and without special cause variation, along with an intervention that has been fully established, typically represent a steady state.

ACTION PLAN: For the ADR example, the answers to the questions are as follows:

1. The intervention was developed and finalized through iterative design among the QI team.

2. Performance has been consistently above target among all endoscopists for 4 consecutive months.

3. ADR is an important quality metric to individual endoscopists as well as hospital leadership. Moreover, because there are increasing models tying reimbursement to funding that are based on adherence to quality indicators, ADR will become more important.

4. If hospitals become mandated to provide scorecard data, the intervention may become redundant. However, the measurement and implications of the data still may be relevant to ongoing QI activities.

Interventions supporting sustainability

Sustainability planning is ideally started at the initiation phase of the project. When choosing a target for change, consideration of organizational factors such as strategic priorities, staff engagement, and leadership support are integral to long-term success. Factors influencing the type of intervention developed should include available funding (both long term and short term), existing information technology (IT) resources, and the ability to incorporate into existing workflow. Considering these factors from the outset will help improve a project’s long-term viability.

A number of toolkits have been produced to guide QI teams through the sustainability process. The National Health Service Institute for Innovation and Improvement has produced a comprehensive guide to sustainability.⁴ The guide provides advice on how to identify opportunities to increase the likelihood of sustainability for your initiative. It is accompanied by a model that can be used to predict success by dividing the factors influencing sustainability into three groups: staff, process, and organization. Each of these has a number of subcategories, and relative significance is attributed to each, with staff factors (clinical leadership engagement, senior leadership engagement, staff involvement in the change, and staff attitudes toward the change) holding the highest weighting. On the basis of the results of the model, the QI team can identify both the likelihood of success as well as opportunities for improvement.

Visual aids are another intervention that promotes sustainability. Visual cues such as posters, buttons, and magnets act as easy reminders for front-line staff. Creating a storyboard at the beginning of the project allows stakeholders to have a broad perspective on both the intervention and sustainability phases.⁵ Ongoing auditing and reporting of results also encourage long-term compliance. This can take the form of posting results of the intervention in the department on a regular basis as well as reports to senior administration. Regular check-ins with all stakeholders are also encouraged. This can be at a monthly staff meeting or a brief “improvement huddle” on a standing basis.

Factors influencing success

Any discussion of QI work must consider context. An understanding of the system one is working within will allow for optimization of system strengths and avoidance of pitfalls because of weaknesses. A lack of attention to context can lead to an unsuccessful project. This could be due to choosing a focus that is not in line with hospital priorities, a project that is asking staff to take on additional tasks without removing others, or developing a solution that requires funding or IT infrastructure that is not readily available.

Any organization has a number of different settings that need to be considered simultaneously. This is most simply divided into microsystem, mesosystem, and macrosystem. Microsystem is defined as the combination of a small team of people who work together on a regular basis. The mesosystem focuses on the integrated care needs of a particular group or population with the same diseases or conditions and provides support for individual microsystems. The macrosystem forms the infrastructure of the larger organization, providing the systems and governance that define the system.⁶ In our example, the microsystem is the endoscopy unit, including physicians, nurses, administrative support, and managers. The mesosystem is composed of the endoscopy unit in addition to the Departments of Gastroenterology and Surgery, the hospital IT team, and the Pathology Department. The macrosystem is the hospital, including senior leadership and administration. Another way of thinking about this is the microsystem is the environment most easily influenced by the individual provider, whereas the macrosystem includes the organizational-level factors that need to be taken into consideration when designing an intervention.

A great number of factors have been proposed to influence sustainability. National Health Service Scotland performed a literature review and met with subject matter experts to determine key factors that require consideration when engaging in activities to sustain and spread QI activities. They produced a guide that focused on 10 factors thought to have the greatest influence.⁶ Although a review of all 10 factors is beyond the scope of this review, we will highlight key ones to consider.

Innovation

The nature of the change greatly influences its likelihood of being sustained. In addition, one must consider the process of the intervention as well as those who will be impacted by the change. Core qualities that predispose to success include the following:⁷

1. Clear advantage compared with current ways

2. Compatibility/integration with current systems and values

3. Simplicity of the change and its implementation

4. Ease of testing

5. Observability of the change and its impact

This list highlights the point that the plan to sustain an intervention needs to start at the design phase and not once the change has been proven successful. Support among users also influences long-term success. Early adopters are those who embrace the intervention or change. Identifying the early adopters and using their support for positive publicity and momentum are integral in any sustainability effort.

ACTION PLAN: In our example, components of the intervention that would predispose to sustainability include choosing an outcome that is aligned with the hospital’s strategic focus (for example, cancer screening and prevention). ADR is already a measurable outcome at the hospital, which facilitates dissemination of results. Alternatively, some of the resistance to change may be due to the increased work to compile and distribute the scorecards monthly.

Organizational culture

Culture has been most simply defined as “the way we do things around here”.⁷ The approach of an organization toward QI will clearly impact its long-term viability. On a macrosystem level, interventions should ideally fit within strategic goals and priorities of organizations to garner maximum support. When promoting the intervention, it may be appropriate to focus on the benefits to the individual group (that is, cost savings to senior administration, time saved to front-line staff). Studies have shown that teams that demonstrate a strong teamwork ethic, have a positive attitude toward the intervention, and where all members know and understand their role on the team were more likely to have sustained success.⁸ In addition, engagement of all key stakeholders early in the process has been correlated with improved long-term outcomes. In a microsystem level, providers can choose to implement the intervention among a well-established team that works well together, ideally where there is a history or prior QI work.

Factors that may make sustaining a QI effort more challenging include interventions that increase time or costs to the organization. Many healthcare organizations may have specific targets set out from their regulatory body. If the intervention lowers the result of one of the targeted outcomes (or does not address those targets at all), it may be met with increased resistance within a system. In cases like this it is integral to use data to demonstrate to senior leadership why this still has tangible benefit to the organization.

ACTION PLAN: In our example, culture can promote sustainability on a microsystem level through reinforcing local success stories. This can be through posting of visual aids in the unit such as posters that display performance or progress boards that chart the status of the intervention. In addition, QI projects can be a regular agenda item at unit meetings, reinforcing their importance to team members.

Leadership

One key component of organizational culture is the influence of leadership. An effective leader will have both technical QI skills and strong interpersonal skills.⁷ Teams where all members feel comfortable making suggestions or voicing concerns are far more likely to succeed, and it is incumbent on leadership to create this environment. This concept is often termed psychological safety and has been directly linked to the inclusiveness of the leader. Team members with psychological safety are more likely to feel like active participants in the process, and this improves their long-term engagement.^7,8 In addition, effective leaders create accountability systems to ensure gains are maintained. These may include regular performance reviews, reminders about the intervention, and assigning responsibility to senior level team members. Finally, celebration of accomplishments reinforces the positive impact of the time and energy invested by members of the team.⁹ The concept of distributed leadership is another key concept. This acknowledges that for any one intervention, there are a number of formal and informal leadership roles, and these can be filled by a number of different individuals.⁷

ACTION PLAN: For our ADR example, sustainability can be promoted through effective leadership. On a microsystem level, one option is the implementation of a weekly Improvement Huddle. This is a 10- to 15-minute meeting within the microsystem that is designed to review current performance and anticipate problems. All team members are encouraged to voice any concerns. On the macrosystem level, quarterly reports to senior administration and presentation of process and results at Grand Rounds may contribute to this goal.

Change management

Change management looks at how an organization approaches the new ways of working. This can be on both a social level and a technical level (often termed Organizational Infrastructure). Creating interventions that integrate with existing systems (data collection, workflow) is ideal for sustainability because it can serve to reinforce the change as standard work. In instances where the change does not immediately integrate, organizations can support change by demonstrating flexibility. This includes modification of existing technology to measure the desired outcome, development of new protocols to integrate the modified workflow, or changing job definitions of team members to demonstrate that the intervention is now considered part of daily responsibilities. Ongoing feedback also reinforces maintenance of performance. This can be through performance reviews for staff members as well as providing data to the appropriate audiences to demonstrate sustained gains.^7,9

ACTION PLAN: For the ADR example, change management can contribute to sustainability through creation of a sustainable data reporting system that integrates current workflow. This will allow ongoing measurement of key metrics and is integral for long-term viability.

Summary

In this final article of a three-part series directed toward gastroenterologists interested in local QI endeavors, we selectively reviewed concepts surrounding sustainability of QI endeavors. This included determining readiness and understanding the factors that influence long-term success on both a macrosystem and microsystem level. Factors under the direct control of the individual practitioner were highlighted to give examples of specific strategies for successful sustainability.

References

1. Thomas, S., Zahn, D. Sustaining improved outcomes: a toolkit. Available at: http://nyshealthfoundation.org/resources-and-reports/resource/sustaining-improved-outcomes-a-toolkit.

2. Buchanan, D., Fitzgerald, L., Ketley, D., et al. No going back: a review of the literature on sustaining organizational change. Int. J Manag Rev. 2005;7:189-205.

3. Sustainability: model and guide. National Health Service Institute for Innovation and Improvement, Leeds, U.K.; 2007.

4. Improvement leaders’ guide to sustainability and spread. NHS Modernisation Agency. Ipswich, England: Ancient House Printing Group; 2002.

5. Nelson, E.C., Batalden, P.B., Godfrey, M.M. Quality by design: a clinical microsystems approach. Jossey-Bass, San Francisco, Calif; 2007.

6. Available at: http://www.ashpfoundation.org/lean.

7. NHS Scotland Quality Improvement Hub. The spread and sustainability of quality improvement in healthcare. 2014. Available at: http://www.qihub.scot.nhs.uk/knowledge-centre/quality-improvement-topics/spread-and-sustainability.aspx.

8. Healthcare Improvement Scotland. Quality improvement: sustainable in any organizational culture? 2013. Available at: http://www.healthcareimprovementscotland.org/previous_resources/benchmarking_report/quality_improvement_report.aspx.

9. 5 Million Lives Campaign. Getting started kit: rapid response teams. Institute for Healthcare Improvement, Cambridge, MA; 2008 (Available at:) www.ihi.org.
 

Dr. Bernstein is in the division of gastroenterology, department of medicine, Sunnybrook Health Sciences Centre; Dr. Weizman is at the Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine, and Institute of Health Policy, Management and Evaluation; Dr. Mosko is in the division of gastroenterology, department of medicine, St. Michael’s Hospital, and the Institute of Health Policy, Management, and Evaluation; Dr. Bollegala is in the division of gastroenterology, department of medicine, Women’s College Hospital; Dr. Brahmania is in the Toronto Center for Liver Diseases, division of gastroenterology, department of medicine, University Health Network; Dr. Liu is in the division of gastroenterology, department of medicine, University Health Network; Dr. Steinhart is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine and Institute of Health Policy, Management, and Evaluation; Dr. Silver is in the division of nephrology, St. Michael’s Hospital; Dr. Nguyen is at Mount Sinai Hospital Centre for Inflammatory Bowel Disease, department of medicine; and Dr. Bell is in the division of internal medicine, department of medicine, Mount Sinai Hospital. All are at the University of Toronto except Dr. Hou, who is at the Houston VA Health Services Research and Development Center of Excellence, Michael DeBakey Veterans Affairs Medical Center, and the section of gastroenterology and hepatology, Baylor College of Medicine, Houston. The authors disclose no conflicts.

Birth defects associated with the Zika virus occurred in 11% of completed pregnancies of mothers infected with the virus during the first trimester, based on data from the U.S. Zika Pregnancy Registry. The findings were published online in JAMA.

Based on preliminary findings from 442 completed pregnancies, 6% of fetuses or infants of women with possible Zika infections at any point during pregnancy had evidence of Zika-associated birth defects, as did 11% of infants or fetuses of women with possible Zika infections during the first trimester only, or during the first trimester and periconceptual period (JAMA. 2016 Dec 13. doi: 10.1001/jama.2016.19006).

Aunt_Spray/Thinkstock

Birth defects associated with the Zika virus occurred in 11% of completed pregnancies of mothers infected with the virus during the first trimester, based on data from the U.S. Zika Pregnancy Registry. The findings were published online in JAMA.

Based on preliminary findings from 442 completed pregnancies, 6% of fetuses or infants of women with possible Zika infections at any point during pregnancy had evidence of Zika-associated birth defects, as did 11% of infants or fetuses of women with possible Zika infections during the first trimester only, or during the first trimester and periconceptual period (JAMA. 2016 Dec 13. doi: 10.1001/jama.2016.19006).

Aunt_Spray/Thinkstock

Birth defects associated with the Zika virus occurred in 11% of completed pregnancies of mothers infected with the virus during the first trimester, based on data from the U.S. Zika Pregnancy Registry. The findings were published online in JAMA.

Based on preliminary findings from 442 completed pregnancies, 6% of fetuses or infants of women with possible Zika infections at any point during pregnancy had evidence of Zika-associated birth defects, as did 11% of infants or fetuses of women with possible Zika infections during the first trimester only, or during the first trimester and periconceptual period (JAMA. 2016 Dec 13. doi: 10.1001/jama.2016.19006).

Aunt_Spray/Thinkstock

The Food and Drug Administration has issued a warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.

“Recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” The studies suggesting a problem with longer or repeat exposures “had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.” Further research is needed, the agency said.

[email protected]

The Food and Drug Administration has issued a warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.

“Recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” The studies suggesting a problem with longer or repeat exposures “had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.” Further research is needed, the agency said.

[email protected]

The Food and Drug Administration has issued a warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.

“Recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” The studies suggesting a problem with longer or repeat exposures “had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.” Further research is needed, the agency said.

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Individuals experiencing chronic GI symptoms waited a mean of 3.7 years to see a health care professional, according to a recent survey.

Thus, for persons with chronic GI issues, inadequate communication may be a factor contributing to underdiagnosis. Fully 60% of patients surveyed cited embarrassment as the reason it was difficult to disclose GI symptoms to a doctor. Nearly half (47%) said they simply wanted to wait to see if their problems would go away. And 66% of patients interviewed had never heard of exocrine pancreatic insufficiency (EPI), while an additional 21% had heard of EPI but were not familiar with it.

iStock/ThinkStock

[email protected]

Individuals experiencing chronic GI symptoms waited a mean of 3.7 years to see a health care professional, according to a recent survey.

Thus, for persons with chronic GI issues, inadequate communication may be a factor contributing to underdiagnosis. Fully 60% of patients surveyed cited embarrassment as the reason it was difficult to disclose GI symptoms to a doctor. Nearly half (47%) said they simply wanted to wait to see if their problems would go away. And 66% of patients interviewed had never heard of exocrine pancreatic insufficiency (EPI), while an additional 21% had heard of EPI but were not familiar with it.

iStock/ThinkStock

[email protected]

Individuals experiencing chronic GI symptoms waited a mean of 3.7 years to see a health care professional, according to a recent survey.

Thus, for persons with chronic GI issues, inadequate communication may be a factor contributing to underdiagnosis. Fully 60% of patients surveyed cited embarrassment as the reason it was difficult to disclose GI symptoms to a doctor. Nearly half (47%) said they simply wanted to wait to see if their problems would go away. And 66% of patients interviewed had never heard of exocrine pancreatic insufficiency (EPI), while an additional 21% had heard of EPI but were not familiar with it.

iStock/ThinkStock

[email protected]

The Centers for Disease Control and Prevention just released a surveillance report describing national estimates of antimicrobial resistance among health care–associated infections (HAIs) in hospitals. The report compiles HAI data submitted to the CDC’s National Healthcare Safety Network (NHSN) from almost all short-term acute care hospitals, inpatient rehabilitation facilities, and long-term acute care hospitals in the country.

These data highlight the broad reach and urgent nature of the drug resistance problem challenging clinicians today; resistance is occurring across different types of infections and patient populations, and dangerous resistance profiles such as carbapenem-resistant Enterobacteriaceae, or CRE, are not going away.

• Prevent infections related to devices and surgeries.

• Prevent the spread of bacteria between patients and between facilities.

• Improve antibiotic use in health care settings.

In addition to drug resistance, this report looked at the frequency of pathogens causing HAIs. The No. 1 and No. 3 most common pathogens among all HAIs were E.coli and Klebsiella, both of which are gram-negative bacteria with the propensity to develop antibiotic resistance.

The data also help identify important differences in the causes of HAIs across each of the infection types. For example, CLABSIs were more commonly due to gram positive organisms and Candida (a fungus), while surgical site infections (SSIs) were most frequently caused by Staph aureus. NHSN tracks SSIs following 39 different types of procedures, and while Staph aureus was the most common pathogen reported overall, the pathogen distributions did vary by surgery site. For example, almost 30% of SSIs following transplant procedures were caused by a species of Enterococcus.

Obviously, there’s far more data in the report than we can discuss here. Fortunately, the CDC’s new Antibiotic Resistance Patient Safety Atlas gives everyone an opportunity to explore these resistance patterns further; color-coded maps and charts included within the Atlas can help you identify common resistance phenotypes in your state and region. While these data give us a national snapshot of resistance profiles, we know there is wide variation among individual health care settings. It is important for providers to become familiar with the common pathogens and resistance profiles in their hospitals and recognize that common infecting organisms vary across different types of infections.

This report underscores the important challenges posed by resistant organisms in hospitals. Combating antibiotic resistance is a top public health priority in the United States and around the world, and having data to direct action is a key part of tackling the problem.

The CDC will continue to use and expand its efforts to monitor antibiotic resistance through surveillance systems such as NHSN, and will remain committed to providing data to support the health care community in efforts to reduce the spread of resistance and improve antibiotic use.
 

Lindsey Weiner, MPH, is an epidemiologist and associate service fellow in the Surveillance Branch, Division of Healthcare Quality Promotion, at the Centers for Disease Control and Prevention.

The Centers for Disease Control and Prevention just released a surveillance report describing national estimates of antimicrobial resistance among health care–associated infections (HAIs) in hospitals. The report compiles HAI data submitted to the CDC’s National Healthcare Safety Network (NHSN) from almost all short-term acute care hospitals, inpatient rehabilitation facilities, and long-term acute care hospitals in the country.

These data highlight the broad reach and urgent nature of the drug resistance problem challenging clinicians today; resistance is occurring across different types of infections and patient populations, and dangerous resistance profiles such as carbapenem-resistant Enterobacteriaceae, or CRE, are not going away.

• Prevent infections related to devices and surgeries.

• Prevent the spread of bacteria between patients and between facilities.

• Improve antibiotic use in health care settings.

In addition to drug resistance, this report looked at the frequency of pathogens causing HAIs. The No. 1 and No. 3 most common pathogens among all HAIs were E.coli and Klebsiella, both of which are gram-negative bacteria with the propensity to develop antibiotic resistance.

The data also help identify important differences in the causes of HAIs across each of the infection types. For example, CLABSIs were more commonly due to gram positive organisms and Candida (a fungus), while surgical site infections (SSIs) were most frequently caused by Staph aureus. NHSN tracks SSIs following 39 different types of procedures, and while Staph aureus was the most common pathogen reported overall, the pathogen distributions did vary by surgery site. For example, almost 30% of SSIs following transplant procedures were caused by a species of Enterococcus.

Obviously, there’s far more data in the report than we can discuss here. Fortunately, the CDC’s new Antibiotic Resistance Patient Safety Atlas gives everyone an opportunity to explore these resistance patterns further; color-coded maps and charts included within the Atlas can help you identify common resistance phenotypes in your state and region. While these data give us a national snapshot of resistance profiles, we know there is wide variation among individual health care settings. It is important for providers to become familiar with the common pathogens and resistance profiles in their hospitals and recognize that common infecting organisms vary across different types of infections.

This report underscores the important challenges posed by resistant organisms in hospitals. Combating antibiotic resistance is a top public health priority in the United States and around the world, and having data to direct action is a key part of tackling the problem.

The CDC will continue to use and expand its efforts to monitor antibiotic resistance through surveillance systems such as NHSN, and will remain committed to providing data to support the health care community in efforts to reduce the spread of resistance and improve antibiotic use.
 

Lindsey Weiner, MPH, is an epidemiologist and associate service fellow in the Surveillance Branch, Division of Healthcare Quality Promotion, at the Centers for Disease Control and Prevention.

The Centers for Disease Control and Prevention just released a surveillance report describing national estimates of antimicrobial resistance among health care–associated infections (HAIs) in hospitals. The report compiles HAI data submitted to the CDC’s National Healthcare Safety Network (NHSN) from almost all short-term acute care hospitals, inpatient rehabilitation facilities, and long-term acute care hospitals in the country.

These data highlight the broad reach and urgent nature of the drug resistance problem challenging clinicians today; resistance is occurring across different types of infections and patient populations, and dangerous resistance profiles such as carbapenem-resistant Enterobacteriaceae, or CRE, are not going away.

• Prevent infections related to devices and surgeries.

• Prevent the spread of bacteria between patients and between facilities.

• Improve antibiotic use in health care settings.

In addition to drug resistance, this report looked at the frequency of pathogens causing HAIs. The No. 1 and No. 3 most common pathogens among all HAIs were E.coli and Klebsiella, both of which are gram-negative bacteria with the propensity to develop antibiotic resistance.

The data also help identify important differences in the causes of HAIs across each of the infection types. For example, CLABSIs were more commonly due to gram positive organisms and Candida (a fungus), while surgical site infections (SSIs) were most frequently caused by Staph aureus. NHSN tracks SSIs following 39 different types of procedures, and while Staph aureus was the most common pathogen reported overall, the pathogen distributions did vary by surgery site. For example, almost 30% of SSIs following transplant procedures were caused by a species of Enterococcus.

Obviously, there’s far more data in the report than we can discuss here. Fortunately, the CDC’s new Antibiotic Resistance Patient Safety Atlas gives everyone an opportunity to explore these resistance patterns further; color-coded maps and charts included within the Atlas can help you identify common resistance phenotypes in your state and region. While these data give us a national snapshot of resistance profiles, we know there is wide variation among individual health care settings. It is important for providers to become familiar with the common pathogens and resistance profiles in their hospitals and recognize that common infecting organisms vary across different types of infections.

This report underscores the important challenges posed by resistant organisms in hospitals. Combating antibiotic resistance is a top public health priority in the United States and around the world, and having data to direct action is a key part of tackling the problem.

The CDC will continue to use and expand its efforts to monitor antibiotic resistance through surveillance systems such as NHSN, and will remain committed to providing data to support the health care community in efforts to reduce the spread of resistance and improve antibiotic use.
 

Lindsey Weiner, MPH, is an epidemiologist and associate service fellow in the Surveillance Branch, Division of Healthcare Quality Promotion, at the Centers for Disease Control and Prevention.

The ulnar collateral ligament (UCL) is the primary restraint to valgus stress between 20° and 125° of motion.^1-5 Overhead athletes, most commonly baseball pitchers, are at risk of developing UCL insufficiency, and dysfunction presents as pain with loss of velocity and control. Some injuries may present acutely while throwing, but many patients, when questioned, report a preceding period of either pain or loss of velocity and control.

Authors have documented a significant rise in elbow injuries in young athletes, especially pitchers.⁶ Extended seasons, higher pitch counts, year-round pitching, pitching while fatigued, and pitching for multiple teams are risk factors for elbow injuries.⁷ Pitchers in the southern United States are more likely to undergo UCL reconstruction than those from the northern states.⁸ Pitchers who also play catcher are at a higher risk due to more total throws than those who pitch and play other positions or pitch only. Throwers with higher velocity are more likely to pitch in showcases, pitch for multiple teams, and pitch with pain and fatigue, and these are all risk factors.⁶ Also, in one study of youth baseball injuries, individuals in the injured group were found to be taller and heavier than those in the uninjured group.⁶ Pitch counts, rest from pitching during the off-season, adequate rest, and ensuring pain-free pitching can lessen the risk of injury.⁶ As expected with the rise in throwing injuries, the rise in medial elbow procedures has risen.⁹

While throwing, stress across the medial elbow has been measured to be nearly 300 N. A maximum varus force during pitching was measured to be 64 N-m at 95° ± 14°.¹⁰ Morrey and An⁴ determined that the UCL generated 54% of the varus force at 90° of flexion. During active pitching, this value is likely reduced due to simultaneous muscle contraction, but if one assumes the UCL bears 54% of the maximal load, the UCL must be able to withstand 34 N-m. The UCL can withstand a maximum valgus torque between 22.7 and 34 N-m^11-13; therefore, during pitching, the UCL is at or above its failure load. After thousands of cycles over many years, one can imagine how the UCL might be injured.

Multiple techniques have been proposed in the surgical treatment of UCL injuries. Jobe¹⁴ pioneered UCL reconstruction in 1974 in Tommy John, a Major League Baseball pitcher. John returned to pitch successfully, and both the UCL and the reconstruction are commonly called by his name. Jobe¹⁴ reported his technique in 1986, and it has remained, with a few modifications, the primary method for reconstruction of the UCL (Figure 1).

Evaluation

A standard evaluation with physical examination and imaging is completed in all throwers with elbow pain. In our prior study,¹⁶ we found that 100% of patients experienced pain during athletic activity and that 96% of throwers complained of pain during late cocking and acceleration phases of the throwing motion. Nearly half reported an acute onset of pain, while 53% were unable to identify a single inciting event. Seventy-five percent of the acute injuries were during competition. Delayed diagnosis was very common, with an average time to diagnosis after onset of symptoms of 6.4 months. Neurologic symptoms were seen in 23% of athletes, most of which were ulnar nerve paresthesias during throwing.¹⁶

Physical examination includes inspection for swelling, hand intrinsic atrophy, neurovascular examination, range of motion, shoulder examination, and elbow stress examination. Range of motion at presentation averaged 5° to 135° with 85° of supination and pronation.¹⁶ All patients need neurologic evaluation for ulnar nerve dysfunction. Tinel test of the cubital tunnel was positive in 21%.¹⁶ Significant ulnar nerve dysfunction, including hand weakness, is much less common but must be well examined and documented. The shoulder must also be evaluated for loss of rotation, which can lead to increased stress on the elbow. An evaluation of mechanics may point out flaws in technique, which may be contributing to elbow stress. The UCL stress examination includes static stress at 30° of flexion, the milking test at 90°, and the moving valgus stress test. The presence of pain directly over the UCL or laxity compared to the uninvolved side is suggestive of UCL injury.

Radiographic evaluation is completed in all patients with concern for UCL injury. Standard x-rays of the elbow, including anteroposterior, medial, and lateral obliques, axial olecranon, and lateral views, are obtained to evaluate bony abnormalities. Fifty-seven percent of our series showed some abnormality, most commonly olecranon osteophyte formation or ectopic calcification within the UCL substance. Stress radiography rarely changed the treatment course and is somewhat difficult to interpret because of the reports documenting normal increased medial elbow opening in the dominant arm of throwing athletes.²¹ Magnetic resonance imaging (MRI) is obtained very commonly in this patient population, and intra-articular contrast is crucial. Partial, undersurface tears are common, and a contrasted study better demonstrates undersurface tears or avulsions. The T-sign as described by Timmerman and colleagues²² using computed tomography (CT) arthrography shows partial undersurface detachment, which can be difficult to see without intra-articular contrast.²² This finding is very well visualized on MRI arthrogram as well (Figure 3).

Nonoperative Management

Nonoperative treatment is recommended for 3 months prior to performing reconstruction. Patients are given complete rest from throwing, but rehabilitation is initiated immediately. Rehabilitation exercises and nonsteroidal anti-inflammatory medications are prescribed, and activities that place valgus stress across the elbow are avoided. After resolution of symptoms, an interval throwing program is initiated, and the athlete is gradually returned to sport. Unfortunately, due to season-specific schedules and time-sensitive demands in high-level throwers, operative treatment is often chosen without an extended period of conservative treatment.

Platelet-rich plasma (PRP) therapy has recently been shown to improve healing rates and promote healing in partial UCL tears,²³ and as orthobiologics are advanced, they will likely play a larger role in the treatment of UCL injuries.

Surgical Technique

At our institution, UCL reconstruction is performed with the modified Jobe technique as described by Azar and colleagues.¹⁷ Arthroscopy prior to reconstruction was routinely performed at our institution until we recognized that arthroscopy rarely changed the preoperative plan.¹⁶ Currently, the presence of anterior pathology such as loose bodies or osteochondral defect is our only indication for arthroscopy before reconstruction.

Ipsilateral palmaris autograft is our current graft of choice. This must be examined preoperatively because 16% of patients have unilateral absence and 9% have bilateral absence.²⁴ In revision cases or in patients with insufficient or absent palmaris, contralateral palmaris followed by contralateral gracilis tendon is used. The contralateral gracilis is chosen because of ease of setup and position of the surgeon during the harvest. Gracilis tendon is also used in cases with bony involvement of the ligament based on the results from Dugas and colleagues.²⁵ Toe extensors, plantaris, and patellar tendon grafts have also been used. One recent study showed that neither graft choice nor diameter affected resistance to valgus stress, and that all reconstruction types restored strength at 60° to 120° of flexion.²⁶

Ulnar nerve transposition is performed in all cases regardless of the presence of preoperative nerve symptoms. A complete decompression is completed proximally to the Arcade of Struthers and distally to the deep portion of the flexor carpi ulnaris. A single fascial sling of medial intermuscular septum originating from the epicondylar attachment is used to stabilize the nerve without compression. At wound closure, the deep fascia on the posterior skin flap is also sewn into the cubital tunnel to prevent the nerve from subluxating back into the groove. A single suture is placed distally closing the muscle fascia to prevent propagation of the fascial incision, which can lead to herniation. Transposition is necessary because of the ulnar nerve exposure required in the modified Jobe technique to allow elevation of the deep flexor muscle mass for ligament exposure.

The reconstruction is completed as described by Jobe¹⁴ but with a few modifications as described by Azar and colleagues¹⁷ and slight adaptations implemented since that time. The flexor-pronator mass is retracted laterally instead of detachment or splitting as described by Thompson and colleagues.²⁷ A subcutaneous rather than a submuscular ulnar nerve transposition is used.

The patient is positioned supine using an arm board. If gracilis tendon is chosen, the contralateral leg is prepped and draped simultaneously. A tourniquet is inflated after exsanguination. A medial approach is performed, and the medial antebrachial nerve is located and protected. The ulnar nerve is then located in the cubital tunnel and mobilized. The neurolysis extends to the deep portion of the flexor carpi ulnaris distally and proximally to the Arcade of Struthers, and the nerve is retracted with a vessel loop. The flexor muscle mass is not elevated from the medial epicondyle; rather, it is retracted anteriorly by small Hohmann retractors. The dissection is carried down to the UCL and found at its attachments to the medial epicondyle and sublime tubercle. If no tear is seen on the superficial surface of the ligament, a longitudinal incision is made through the ligament. Undersurface tears, partial tears, and avulsions can then be identified (Figure 4).

Postoperative Rehabilitation

A standardized postoperative 4-phase rehabilitation program for ulnar collateral reconstruction is followed as described by Wilk and colleagues.^28-30 The first phase begins immediately after surgery and continues for 4 weeks. During surgery, the patient’s elbow is placed in a compression dressing with a posterior splint to immobilize the elbow in 90° of flexion with wrist motion for 1 week to allow initial healing. Full range of motion of the elbow joint is restored by the end of the fifth to sixth week after surgery.

During phase II (weeks 4-10), a progressive isotonic strengthening program is initiated. Exercises are focused on scapular, rotator cuff, deltoid, and arm musculature. Shoulder range of motion and stretching exercises are performed during this phase and the Thrower’s Ten exercise program is initiated. Any adaptations or strength deficits are addressed during this phase.

During the advanced strengthening phase (phase III), from weeks 10 to 16, a sport-specific exercise/rehabilitation program is initiated. During this phase, stretching and flexibility exercises are performed to enhance strength, power, and endurance. During this phase the patient is placed on the advanced Thrower’s Ten program. Isotonic strengthening exercises are progressed, and at week 12, the athlete is allowed to begin an isotonic lifting program, including bench press, seated rowing, latissimus dorsi pull downs, triceps push downs, and biceps curls. In addition, the athlete performs specific exercises to emphasize sport-specific movements. At week 12, overhead athletes begin a 2-hand plyometric throwing program, and at 14 weeks, a 1-hand plyometric throwing program. Furthermore, endurance exercises, core stability, and leg strengthening are emphasized during phase III. Phase IV, the return to activity phase (week 16 and beyond), is characterized by the initiation of an interval throwing program. The patient is instructed to continue his stretching and strengthening program. An interval throwing program off the mound is gradually initiated at 5 to 6 months postoperative and a gradual return to competition is initiated for pitchers at 9 months and for position players 6 to 7 months postoperative.

Discussion

Results after ulnar collateral reconstruction have been good. In our series of 743 patients, 83% returned to the same or higher level at an average of 11.6 months.¹⁶ There was a 4% major complication rate and 16% minor complication rate. Major complications included medial epicondyle fracture (0.5%), significant ulnar nerve dysfunction (1 patient), rupture of graft (1%), and graft site infection. Sixteen percent of patients had ulnar nerve dysfunction, and 82% of these resolved within 6 weeks. All but 1 patient’s paresthesias resolved within 1 year.¹⁶ The 10-year follow-up of this group of patients included 256 patients and was reported by Osbahr and colleagues³¹ in 2014. Retirement from baseball was due to reasons other than the elbow in 86%, and 98% were still able to throw on at least a recreational level. The overall longevity was 3.6 years, with 2.9 years at pre-injury level or higher. Statistically, pitchers performed at a higher level after reconstruction.³¹

A recent review by Erickson and colleagues⁹ showed an overall 82% excellent and 8% good result when evaluating different techniques, including the American Sports Medicine Institute (ASMI) modification of Jobe’s technique, docking technique, and Jobe’s technique. With an overall complication rate of 10% (75% of which was transient ulnar neuritis), the procedure was deemed overall a safe surgical option. Collegiate athletes had the highest return to sport (95%) compared with high school athletes (89%) and professional athletes (86%). The docking technique had the highest rate of return to play (97%) compared with ASMI technique (93%) and Jobe technique (66%).⁹ Results after repair have not been as good as reconstruction, as reported in 2 studies.^16,32 Savoie and colleagues,¹⁵ however, reported 93% good/excellent results after primary UCL repair alone.

Another recent review of outcomes showed an overall return to same or higher level was best with docking or modified docking techniques (90.4% and 91.3%, respectively).¹⁹ Overall return with modified Jobe technique was 77%.¹⁹ O’Brien and colleagues²⁰ performed a review of 33 patients with either modified Jobe or docking technique that showed 81% return to same or higher level with modified Jobe vs 92% with docking technique. The Kerlan-Jobe Orthopaedic Clinic scores were higher in the modified Jobe group (79 vs 74) and the docking technique group returned to play nearly 1 month sooner (12.4 months vs 11.8 months).²⁰ However, comparing different techniques in a heterogenous patient population over 40 years is difficult. Many of the modified Jobe technique cases were performed in the early evolution of the rehabilitation and return-to-play programs. We believe that the current modified Jobe technique has results equal to any other variation.

Despite good results with reconstructions, the recovery is lengthy and most pitchers cannot fully return to competition level for 12 to 18 months. Extensive research has been performed in exploring alternatives to the traditional reconstruction. Advancements in orthobiologics and development of new surgical options seem to provide an alternative to reconstruction, and may allow faster return to competition with less morbidity.

PRP has been at the forefront of orthopedic research for the last 2 decades, mostly focused in tendon and bone healing. Due to the release of many inflammatory mediators, PRP is theorized to initiate a healing response with growth factors that can direct healing towards normal tissue.³³ Two main types of PRP are reported based on the presence or absence of leukocytes. PRP has been studied in many applications, but only one clinical study on the UCL has been published to date. Podesta and colleagues²³ injected PRP into the elbow of 34 baseball players with MRI-confirmed partial UCL tear. The athletes then underwent a rehabilitation program, which limited stress across the UCL. Type 1A PRP was used (leukocyte-rich, unactivated, 5x or greater platelet concentration³³). Athletes were allowed to return to sport based on symptoms and examination findings. Eighty-eight percent returned to same level of play without complaints at average 70 week follow-up, and average return to play ranged from 10 to 15 weeks.²³ No specific data were given on the 16 pitchers in the group, but with such a high rate of return, PRP needs to be further evaluated in the treatment of UCL injuries.

Another recent study from Dugas and colleagues¹⁸ presented primary UCL repair using a tape augment (InternalBrace, Arthrex). Nine matched cadaver elbows underwent UCL sectioning and then either modified Jobe reconstruction or primary repair of the UCL with placement of the InternalBrace. The biomechanical data showed the repair with internal brace to have slightly less gap, more stiffness, and higher failure strength, although these findings were not statistically significant.¹⁸ This bone-preserving technique with less exposure and healing of the native ligament may be another step towards good results with a quicker return to throwing.

Conclusion

UCL injuries can be disabling in throwers. Reconstruction has afforded throwers a high rate of return to preinjury function or better, and several techniques have been presented that produce acceptable results. Overall complication rates range from 10% to 15%, and the majority of complications are transient ulnar neuropraxias. Orthobiologics and repair with augmentation have more recently offered additional options that may improve success of nonoperative treatment or allow less-invasive surgical treatment. Increased involvement in youth sports and early specialization is driving injury rates in young athletes. The orthopedic community must continue to look for better ways to prevent these injuries and investigate better methods to return athletes to high-level competition.

Am J Orthop. 2016;45(7):E534-E540. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The ulnar collateral ligament (UCL) is the primary restraint to valgus stress between 20° and 125° of motion.^1-5 Overhead athletes, most commonly baseball pitchers, are at risk of developing UCL insufficiency, and dysfunction presents as pain with loss of velocity and control. Some injuries may present acutely while throwing, but many patients, when questioned, report a preceding period of either pain or loss of velocity and control.

Authors have documented a significant rise in elbow injuries in young athletes, especially pitchers.⁶ Extended seasons, higher pitch counts, year-round pitching, pitching while fatigued, and pitching for multiple teams are risk factors for elbow injuries.⁷ Pitchers in the southern United States are more likely to undergo UCL reconstruction than those from the northern states.⁸ Pitchers who also play catcher are at a higher risk due to more total throws than those who pitch and play other positions or pitch only. Throwers with higher velocity are more likely to pitch in showcases, pitch for multiple teams, and pitch with pain and fatigue, and these are all risk factors.⁶ Also, in one study of youth baseball injuries, individuals in the injured group were found to be taller and heavier than those in the uninjured group.⁶ Pitch counts, rest from pitching during the off-season, adequate rest, and ensuring pain-free pitching can lessen the risk of injury.⁶ As expected with the rise in throwing injuries, the rise in medial elbow procedures has risen.⁹

While throwing, stress across the medial elbow has been measured to be nearly 300 N. A maximum varus force during pitching was measured to be 64 N-m at 95° ± 14°.¹⁰ Morrey and An⁴ determined that the UCL generated 54% of the varus force at 90° of flexion. During active pitching, this value is likely reduced due to simultaneous muscle contraction, but if one assumes the UCL bears 54% of the maximal load, the UCL must be able to withstand 34 N-m. The UCL can withstand a maximum valgus torque between 22.7 and 34 N-m^11-13; therefore, during pitching, the UCL is at or above its failure load. After thousands of cycles over many years, one can imagine how the UCL might be injured.

Multiple techniques have been proposed in the surgical treatment of UCL injuries. Jobe¹⁴ pioneered UCL reconstruction in 1974 in Tommy John, a Major League Baseball pitcher. John returned to pitch successfully, and both the UCL and the reconstruction are commonly called by his name. Jobe¹⁴ reported his technique in 1986, and it has remained, with a few modifications, the primary method for reconstruction of the UCL (Figure 1).

Evaluation

A standard evaluation with physical examination and imaging is completed in all throwers with elbow pain. In our prior study,¹⁶ we found that 100% of patients experienced pain during athletic activity and that 96% of throwers complained of pain during late cocking and acceleration phases of the throwing motion. Nearly half reported an acute onset of pain, while 53% were unable to identify a single inciting event. Seventy-five percent of the acute injuries were during competition. Delayed diagnosis was very common, with an average time to diagnosis after onset of symptoms of 6.4 months. Neurologic symptoms were seen in 23% of athletes, most of which were ulnar nerve paresthesias during throwing.¹⁶

Physical examination includes inspection for swelling, hand intrinsic atrophy, neurovascular examination, range of motion, shoulder examination, and elbow stress examination. Range of motion at presentation averaged 5° to 135° with 85° of supination and pronation.¹⁶ All patients need neurologic evaluation for ulnar nerve dysfunction. Tinel test of the cubital tunnel was positive in 21%.¹⁶ Significant ulnar nerve dysfunction, including hand weakness, is much less common but must be well examined and documented. The shoulder must also be evaluated for loss of rotation, which can lead to increased stress on the elbow. An evaluation of mechanics may point out flaws in technique, which may be contributing to elbow stress. The UCL stress examination includes static stress at 30° of flexion, the milking test at 90°, and the moving valgus stress test. The presence of pain directly over the UCL or laxity compared to the uninvolved side is suggestive of UCL injury.

Radiographic evaluation is completed in all patients with concern for UCL injury. Standard x-rays of the elbow, including anteroposterior, medial, and lateral obliques, axial olecranon, and lateral views, are obtained to evaluate bony abnormalities. Fifty-seven percent of our series showed some abnormality, most commonly olecranon osteophyte formation or ectopic calcification within the UCL substance. Stress radiography rarely changed the treatment course and is somewhat difficult to interpret because of the reports documenting normal increased medial elbow opening in the dominant arm of throwing athletes.²¹ Magnetic resonance imaging (MRI) is obtained very commonly in this patient population, and intra-articular contrast is crucial. Partial, undersurface tears are common, and a contrasted study better demonstrates undersurface tears or avulsions. The T-sign as described by Timmerman and colleagues²² using computed tomography (CT) arthrography shows partial undersurface detachment, which can be difficult to see without intra-articular contrast.²² This finding is very well visualized on MRI arthrogram as well (Figure 3).

Nonoperative Management

Nonoperative treatment is recommended for 3 months prior to performing reconstruction. Patients are given complete rest from throwing, but rehabilitation is initiated immediately. Rehabilitation exercises and nonsteroidal anti-inflammatory medications are prescribed, and activities that place valgus stress across the elbow are avoided. After resolution of symptoms, an interval throwing program is initiated, and the athlete is gradually returned to sport. Unfortunately, due to season-specific schedules and time-sensitive demands in high-level throwers, operative treatment is often chosen without an extended period of conservative treatment.

Platelet-rich plasma (PRP) therapy has recently been shown to improve healing rates and promote healing in partial UCL tears,²³ and as orthobiologics are advanced, they will likely play a larger role in the treatment of UCL injuries.

Surgical Technique

At our institution, UCL reconstruction is performed with the modified Jobe technique as described by Azar and colleagues.¹⁷ Arthroscopy prior to reconstruction was routinely performed at our institution until we recognized that arthroscopy rarely changed the preoperative plan.¹⁶ Currently, the presence of anterior pathology such as loose bodies or osteochondral defect is our only indication for arthroscopy before reconstruction.

Ipsilateral palmaris autograft is our current graft of choice. This must be examined preoperatively because 16% of patients have unilateral absence and 9% have bilateral absence.²⁴ In revision cases or in patients with insufficient or absent palmaris, contralateral palmaris followed by contralateral gracilis tendon is used. The contralateral gracilis is chosen because of ease of setup and position of the surgeon during the harvest. Gracilis tendon is also used in cases with bony involvement of the ligament based on the results from Dugas and colleagues.²⁵ Toe extensors, plantaris, and patellar tendon grafts have also been used. One recent study showed that neither graft choice nor diameter affected resistance to valgus stress, and that all reconstruction types restored strength at 60° to 120° of flexion.²⁶

Ulnar nerve transposition is performed in all cases regardless of the presence of preoperative nerve symptoms. A complete decompression is completed proximally to the Arcade of Struthers and distally to the deep portion of the flexor carpi ulnaris. A single fascial sling of medial intermuscular septum originating from the epicondylar attachment is used to stabilize the nerve without compression. At wound closure, the deep fascia on the posterior skin flap is also sewn into the cubital tunnel to prevent the nerve from subluxating back into the groove. A single suture is placed distally closing the muscle fascia to prevent propagation of the fascial incision, which can lead to herniation. Transposition is necessary because of the ulnar nerve exposure required in the modified Jobe technique to allow elevation of the deep flexor muscle mass for ligament exposure.

The reconstruction is completed as described by Jobe¹⁴ but with a few modifications as described by Azar and colleagues¹⁷ and slight adaptations implemented since that time. The flexor-pronator mass is retracted laterally instead of detachment or splitting as described by Thompson and colleagues.²⁷ A subcutaneous rather than a submuscular ulnar nerve transposition is used.

The patient is positioned supine using an arm board. If gracilis tendon is chosen, the contralateral leg is prepped and draped simultaneously. A tourniquet is inflated after exsanguination. A medial approach is performed, and the medial antebrachial nerve is located and protected. The ulnar nerve is then located in the cubital tunnel and mobilized. The neurolysis extends to the deep portion of the flexor carpi ulnaris distally and proximally to the Arcade of Struthers, and the nerve is retracted with a vessel loop. The flexor muscle mass is not elevated from the medial epicondyle; rather, it is retracted anteriorly by small Hohmann retractors. The dissection is carried down to the UCL and found at its attachments to the medial epicondyle and sublime tubercle. If no tear is seen on the superficial surface of the ligament, a longitudinal incision is made through the ligament. Undersurface tears, partial tears, and avulsions can then be identified (Figure 4).

Postoperative Rehabilitation

A standardized postoperative 4-phase rehabilitation program for ulnar collateral reconstruction is followed as described by Wilk and colleagues.^28-30 The first phase begins immediately after surgery and continues for 4 weeks. During surgery, the patient’s elbow is placed in a compression dressing with a posterior splint to immobilize the elbow in 90° of flexion with wrist motion for 1 week to allow initial healing. Full range of motion of the elbow joint is restored by the end of the fifth to sixth week after surgery.

During phase II (weeks 4-10), a progressive isotonic strengthening program is initiated. Exercises are focused on scapular, rotator cuff, deltoid, and arm musculature. Shoulder range of motion and stretching exercises are performed during this phase and the Thrower’s Ten exercise program is initiated. Any adaptations or strength deficits are addressed during this phase.

During the advanced strengthening phase (phase III), from weeks 10 to 16, a sport-specific exercise/rehabilitation program is initiated. During this phase, stretching and flexibility exercises are performed to enhance strength, power, and endurance. During this phase the patient is placed on the advanced Thrower’s Ten program. Isotonic strengthening exercises are progressed, and at week 12, the athlete is allowed to begin an isotonic lifting program, including bench press, seated rowing, latissimus dorsi pull downs, triceps push downs, and biceps curls. In addition, the athlete performs specific exercises to emphasize sport-specific movements. At week 12, overhead athletes begin a 2-hand plyometric throwing program, and at 14 weeks, a 1-hand plyometric throwing program. Furthermore, endurance exercises, core stability, and leg strengthening are emphasized during phase III. Phase IV, the return to activity phase (week 16 and beyond), is characterized by the initiation of an interval throwing program. The patient is instructed to continue his stretching and strengthening program. An interval throwing program off the mound is gradually initiated at 5 to 6 months postoperative and a gradual return to competition is initiated for pitchers at 9 months and for position players 6 to 7 months postoperative.

Discussion

Results after ulnar collateral reconstruction have been good. In our series of 743 patients, 83% returned to the same or higher level at an average of 11.6 months.¹⁶ There was a 4% major complication rate and 16% minor complication rate. Major complications included medial epicondyle fracture (0.5%), significant ulnar nerve dysfunction (1 patient), rupture of graft (1%), and graft site infection. Sixteen percent of patients had ulnar nerve dysfunction, and 82% of these resolved within 6 weeks. All but 1 patient’s paresthesias resolved within 1 year.¹⁶ The 10-year follow-up of this group of patients included 256 patients and was reported by Osbahr and colleagues³¹ in 2014. Retirement from baseball was due to reasons other than the elbow in 86%, and 98% were still able to throw on at least a recreational level. The overall longevity was 3.6 years, with 2.9 years at pre-injury level or higher. Statistically, pitchers performed at a higher level after reconstruction.³¹

A recent review by Erickson and colleagues⁹ showed an overall 82% excellent and 8% good result when evaluating different techniques, including the American Sports Medicine Institute (ASMI) modification of Jobe’s technique, docking technique, and Jobe’s technique. With an overall complication rate of 10% (75% of which was transient ulnar neuritis), the procedure was deemed overall a safe surgical option. Collegiate athletes had the highest return to sport (95%) compared with high school athletes (89%) and professional athletes (86%). The docking technique had the highest rate of return to play (97%) compared with ASMI technique (93%) and Jobe technique (66%).⁹ Results after repair have not been as good as reconstruction, as reported in 2 studies.^16,32 Savoie and colleagues,¹⁵ however, reported 93% good/excellent results after primary UCL repair alone.

Another recent review of outcomes showed an overall return to same or higher level was best with docking or modified docking techniques (90.4% and 91.3%, respectively).¹⁹ Overall return with modified Jobe technique was 77%.¹⁹ O’Brien and colleagues²⁰ performed a review of 33 patients with either modified Jobe or docking technique that showed 81% return to same or higher level with modified Jobe vs 92% with docking technique. The Kerlan-Jobe Orthopaedic Clinic scores were higher in the modified Jobe group (79 vs 74) and the docking technique group returned to play nearly 1 month sooner (12.4 months vs 11.8 months).²⁰ However, comparing different techniques in a heterogenous patient population over 40 years is difficult. Many of the modified Jobe technique cases were performed in the early evolution of the rehabilitation and return-to-play programs. We believe that the current modified Jobe technique has results equal to any other variation.

Despite good results with reconstructions, the recovery is lengthy and most pitchers cannot fully return to competition level for 12 to 18 months. Extensive research has been performed in exploring alternatives to the traditional reconstruction. Advancements in orthobiologics and development of new surgical options seem to provide an alternative to reconstruction, and may allow faster return to competition with less morbidity.

PRP has been at the forefront of orthopedic research for the last 2 decades, mostly focused in tendon and bone healing. Due to the release of many inflammatory mediators, PRP is theorized to initiate a healing response with growth factors that can direct healing towards normal tissue.³³ Two main types of PRP are reported based on the presence or absence of leukocytes. PRP has been studied in many applications, but only one clinical study on the UCL has been published to date. Podesta and colleagues²³ injected PRP into the elbow of 34 baseball players with MRI-confirmed partial UCL tear. The athletes then underwent a rehabilitation program, which limited stress across the UCL. Type 1A PRP was used (leukocyte-rich, unactivated, 5x or greater platelet concentration³³). Athletes were allowed to return to sport based on symptoms and examination findings. Eighty-eight percent returned to same level of play without complaints at average 70 week follow-up, and average return to play ranged from 10 to 15 weeks.²³ No specific data were given on the 16 pitchers in the group, but with such a high rate of return, PRP needs to be further evaluated in the treatment of UCL injuries.

Another recent study from Dugas and colleagues¹⁸ presented primary UCL repair using a tape augment (InternalBrace, Arthrex). Nine matched cadaver elbows underwent UCL sectioning and then either modified Jobe reconstruction or primary repair of the UCL with placement of the InternalBrace. The biomechanical data showed the repair with internal brace to have slightly less gap, more stiffness, and higher failure strength, although these findings were not statistically significant.¹⁸ This bone-preserving technique with less exposure and healing of the native ligament may be another step towards good results with a quicker return to throwing.

Conclusion

UCL injuries can be disabling in throwers. Reconstruction has afforded throwers a high rate of return to preinjury function or better, and several techniques have been presented that produce acceptable results. Overall complication rates range from 10% to 15%, and the majority of complications are transient ulnar neuropraxias. Orthobiologics and repair with augmentation have more recently offered additional options that may improve success of nonoperative treatment or allow less-invasive surgical treatment. Increased involvement in youth sports and early specialization is driving injury rates in young athletes. The orthopedic community must continue to look for better ways to prevent these injuries and investigate better methods to return athletes to high-level competition.

Am J Orthop. 2016;45(7):E534-E540. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The ulnar collateral ligament (UCL) is the primary restraint to valgus stress between 20° and 125° of motion.^1-5 Overhead athletes, most commonly baseball pitchers, are at risk of developing UCL insufficiency, and dysfunction presents as pain with loss of velocity and control. Some injuries may present acutely while throwing, but many patients, when questioned, report a preceding period of either pain or loss of velocity and control.

Authors have documented a significant rise in elbow injuries in young athletes, especially pitchers.⁶ Extended seasons, higher pitch counts, year-round pitching, pitching while fatigued, and pitching for multiple teams are risk factors for elbow injuries.⁷ Pitchers in the southern United States are more likely to undergo UCL reconstruction than those from the northern states.⁸ Pitchers who also play catcher are at a higher risk due to more total throws than those who pitch and play other positions or pitch only. Throwers with higher velocity are more likely to pitch in showcases, pitch for multiple teams, and pitch with pain and fatigue, and these are all risk factors.⁶ Also, in one study of youth baseball injuries, individuals in the injured group were found to be taller and heavier than those in the uninjured group.⁶ Pitch counts, rest from pitching during the off-season, adequate rest, and ensuring pain-free pitching can lessen the risk of injury.⁶ As expected with the rise in throwing injuries, the rise in medial elbow procedures has risen.⁹

While throwing, stress across the medial elbow has been measured to be nearly 300 N. A maximum varus force during pitching was measured to be 64 N-m at 95° ± 14°.¹⁰ Morrey and An⁴ determined that the UCL generated 54% of the varus force at 90° of flexion. During active pitching, this value is likely reduced due to simultaneous muscle contraction, but if one assumes the UCL bears 54% of the maximal load, the UCL must be able to withstand 34 N-m. The UCL can withstand a maximum valgus torque between 22.7 and 34 N-m^11-13; therefore, during pitching, the UCL is at or above its failure load. After thousands of cycles over many years, one can imagine how the UCL might be injured.

Multiple techniques have been proposed in the surgical treatment of UCL injuries. Jobe¹⁴ pioneered UCL reconstruction in 1974 in Tommy John, a Major League Baseball pitcher. John returned to pitch successfully, and both the UCL and the reconstruction are commonly called by his name. Jobe¹⁴ reported his technique in 1986, and it has remained, with a few modifications, the primary method for reconstruction of the UCL (Figure 1).

Evaluation

A standard evaluation with physical examination and imaging is completed in all throwers with elbow pain. In our prior study,¹⁶ we found that 100% of patients experienced pain during athletic activity and that 96% of throwers complained of pain during late cocking and acceleration phases of the throwing motion. Nearly half reported an acute onset of pain, while 53% were unable to identify a single inciting event. Seventy-five percent of the acute injuries were during competition. Delayed diagnosis was very common, with an average time to diagnosis after onset of symptoms of 6.4 months. Neurologic symptoms were seen in 23% of athletes, most of which were ulnar nerve paresthesias during throwing.¹⁶

Physical examination includes inspection for swelling, hand intrinsic atrophy, neurovascular examination, range of motion, shoulder examination, and elbow stress examination. Range of motion at presentation averaged 5° to 135° with 85° of supination and pronation.¹⁶ All patients need neurologic evaluation for ulnar nerve dysfunction. Tinel test of the cubital tunnel was positive in 21%.¹⁶ Significant ulnar nerve dysfunction, including hand weakness, is much less common but must be well examined and documented. The shoulder must also be evaluated for loss of rotation, which can lead to increased stress on the elbow. An evaluation of mechanics may point out flaws in technique, which may be contributing to elbow stress. The UCL stress examination includes static stress at 30° of flexion, the milking test at 90°, and the moving valgus stress test. The presence of pain directly over the UCL or laxity compared to the uninvolved side is suggestive of UCL injury.

Radiographic evaluation is completed in all patients with concern for UCL injury. Standard x-rays of the elbow, including anteroposterior, medial, and lateral obliques, axial olecranon, and lateral views, are obtained to evaluate bony abnormalities. Fifty-seven percent of our series showed some abnormality, most commonly olecranon osteophyte formation or ectopic calcification within the UCL substance. Stress radiography rarely changed the treatment course and is somewhat difficult to interpret because of the reports documenting normal increased medial elbow opening in the dominant arm of throwing athletes.²¹ Magnetic resonance imaging (MRI) is obtained very commonly in this patient population, and intra-articular contrast is crucial. Partial, undersurface tears are common, and a contrasted study better demonstrates undersurface tears or avulsions. The T-sign as described by Timmerman and colleagues²² using computed tomography (CT) arthrography shows partial undersurface detachment, which can be difficult to see without intra-articular contrast.²² This finding is very well visualized on MRI arthrogram as well (Figure 3).

Nonoperative Management

Nonoperative treatment is recommended for 3 months prior to performing reconstruction. Patients are given complete rest from throwing, but rehabilitation is initiated immediately. Rehabilitation exercises and nonsteroidal anti-inflammatory medications are prescribed, and activities that place valgus stress across the elbow are avoided. After resolution of symptoms, an interval throwing program is initiated, and the athlete is gradually returned to sport. Unfortunately, due to season-specific schedules and time-sensitive demands in high-level throwers, operative treatment is often chosen without an extended period of conservative treatment.

Platelet-rich plasma (PRP) therapy has recently been shown to improve healing rates and promote healing in partial UCL tears,²³ and as orthobiologics are advanced, they will likely play a larger role in the treatment of UCL injuries.

Surgical Technique

At our institution, UCL reconstruction is performed with the modified Jobe technique as described by Azar and colleagues.¹⁷ Arthroscopy prior to reconstruction was routinely performed at our institution until we recognized that arthroscopy rarely changed the preoperative plan.¹⁶ Currently, the presence of anterior pathology such as loose bodies or osteochondral defect is our only indication for arthroscopy before reconstruction.

Ipsilateral palmaris autograft is our current graft of choice. This must be examined preoperatively because 16% of patients have unilateral absence and 9% have bilateral absence.²⁴ In revision cases or in patients with insufficient or absent palmaris, contralateral palmaris followed by contralateral gracilis tendon is used. The contralateral gracilis is chosen because of ease of setup and position of the surgeon during the harvest. Gracilis tendon is also used in cases with bony involvement of the ligament based on the results from Dugas and colleagues.²⁵ Toe extensors, plantaris, and patellar tendon grafts have also been used. One recent study showed that neither graft choice nor diameter affected resistance to valgus stress, and that all reconstruction types restored strength at 60° to 120° of flexion.²⁶

Ulnar nerve transposition is performed in all cases regardless of the presence of preoperative nerve symptoms. A complete decompression is completed proximally to the Arcade of Struthers and distally to the deep portion of the flexor carpi ulnaris. A single fascial sling of medial intermuscular septum originating from the epicondylar attachment is used to stabilize the nerve without compression. At wound closure, the deep fascia on the posterior skin flap is also sewn into the cubital tunnel to prevent the nerve from subluxating back into the groove. A single suture is placed distally closing the muscle fascia to prevent propagation of the fascial incision, which can lead to herniation. Transposition is necessary because of the ulnar nerve exposure required in the modified Jobe technique to allow elevation of the deep flexor muscle mass for ligament exposure.

The reconstruction is completed as described by Jobe¹⁴ but with a few modifications as described by Azar and colleagues¹⁷ and slight adaptations implemented since that time. The flexor-pronator mass is retracted laterally instead of detachment or splitting as described by Thompson and colleagues.²⁷ A subcutaneous rather than a submuscular ulnar nerve transposition is used.

The patient is positioned supine using an arm board. If gracilis tendon is chosen, the contralateral leg is prepped and draped simultaneously. A tourniquet is inflated after exsanguination. A medial approach is performed, and the medial antebrachial nerve is located and protected. The ulnar nerve is then located in the cubital tunnel and mobilized. The neurolysis extends to the deep portion of the flexor carpi ulnaris distally and proximally to the Arcade of Struthers, and the nerve is retracted with a vessel loop. The flexor muscle mass is not elevated from the medial epicondyle; rather, it is retracted anteriorly by small Hohmann retractors. The dissection is carried down to the UCL and found at its attachments to the medial epicondyle and sublime tubercle. If no tear is seen on the superficial surface of the ligament, a longitudinal incision is made through the ligament. Undersurface tears, partial tears, and avulsions can then be identified (Figure 4).

Postoperative Rehabilitation

A standardized postoperative 4-phase rehabilitation program for ulnar collateral reconstruction is followed as described by Wilk and colleagues.^28-30 The first phase begins immediately after surgery and continues for 4 weeks. During surgery, the patient’s elbow is placed in a compression dressing with a posterior splint to immobilize the elbow in 90° of flexion with wrist motion for 1 week to allow initial healing. Full range of motion of the elbow joint is restored by the end of the fifth to sixth week after surgery.

During phase II (weeks 4-10), a progressive isotonic strengthening program is initiated. Exercises are focused on scapular, rotator cuff, deltoid, and arm musculature. Shoulder range of motion and stretching exercises are performed during this phase and the Thrower’s Ten exercise program is initiated. Any adaptations or strength deficits are addressed during this phase.

During the advanced strengthening phase (phase III), from weeks 10 to 16, a sport-specific exercise/rehabilitation program is initiated. During this phase, stretching and flexibility exercises are performed to enhance strength, power, and endurance. During this phase the patient is placed on the advanced Thrower’s Ten program. Isotonic strengthening exercises are progressed, and at week 12, the athlete is allowed to begin an isotonic lifting program, including bench press, seated rowing, latissimus dorsi pull downs, triceps push downs, and biceps curls. In addition, the athlete performs specific exercises to emphasize sport-specific movements. At week 12, overhead athletes begin a 2-hand plyometric throwing program, and at 14 weeks, a 1-hand plyometric throwing program. Furthermore, endurance exercises, core stability, and leg strengthening are emphasized during phase III. Phase IV, the return to activity phase (week 16 and beyond), is characterized by the initiation of an interval throwing program. The patient is instructed to continue his stretching and strengthening program. An interval throwing program off the mound is gradually initiated at 5 to 6 months postoperative and a gradual return to competition is initiated for pitchers at 9 months and for position players 6 to 7 months postoperative.

Discussion

Results after ulnar collateral reconstruction have been good. In our series of 743 patients, 83% returned to the same or higher level at an average of 11.6 months.¹⁶ There was a 4% major complication rate and 16% minor complication rate. Major complications included medial epicondyle fracture (0.5%), significant ulnar nerve dysfunction (1 patient), rupture of graft (1%), and graft site infection. Sixteen percent of patients had ulnar nerve dysfunction, and 82% of these resolved within 6 weeks. All but 1 patient’s paresthesias resolved within 1 year.¹⁶ The 10-year follow-up of this group of patients included 256 patients and was reported by Osbahr and colleagues³¹ in 2014. Retirement from baseball was due to reasons other than the elbow in 86%, and 98% were still able to throw on at least a recreational level. The overall longevity was 3.6 years, with 2.9 years at pre-injury level or higher. Statistically, pitchers performed at a higher level after reconstruction.³¹

A recent review by Erickson and colleagues⁹ showed an overall 82% excellent and 8% good result when evaluating different techniques, including the American Sports Medicine Institute (ASMI) modification of Jobe’s technique, docking technique, and Jobe’s technique. With an overall complication rate of 10% (75% of which was transient ulnar neuritis), the procedure was deemed overall a safe surgical option. Collegiate athletes had the highest return to sport (95%) compared with high school athletes (89%) and professional athletes (86%). The docking technique had the highest rate of return to play (97%) compared with ASMI technique (93%) and Jobe technique (66%).⁹ Results after repair have not been as good as reconstruction, as reported in 2 studies.^16,32 Savoie and colleagues,¹⁵ however, reported 93% good/excellent results after primary UCL repair alone.

Another recent review of outcomes showed an overall return to same or higher level was best with docking or modified docking techniques (90.4% and 91.3%, respectively).¹⁹ Overall return with modified Jobe technique was 77%.¹⁹ O’Brien and colleagues²⁰ performed a review of 33 patients with either modified Jobe or docking technique that showed 81% return to same or higher level with modified Jobe vs 92% with docking technique. The Kerlan-Jobe Orthopaedic Clinic scores were higher in the modified Jobe group (79 vs 74) and the docking technique group returned to play nearly 1 month sooner (12.4 months vs 11.8 months).²⁰ However, comparing different techniques in a heterogenous patient population over 40 years is difficult. Many of the modified Jobe technique cases were performed in the early evolution of the rehabilitation and return-to-play programs. We believe that the current modified Jobe technique has results equal to any other variation.

Despite good results with reconstructions, the recovery is lengthy and most pitchers cannot fully return to competition level for 12 to 18 months. Extensive research has been performed in exploring alternatives to the traditional reconstruction. Advancements in orthobiologics and development of new surgical options seem to provide an alternative to reconstruction, and may allow faster return to competition with less morbidity.

PRP has been at the forefront of orthopedic research for the last 2 decades, mostly focused in tendon and bone healing. Due to the release of many inflammatory mediators, PRP is theorized to initiate a healing response with growth factors that can direct healing towards normal tissue.³³ Two main types of PRP are reported based on the presence or absence of leukocytes. PRP has been studied in many applications, but only one clinical study on the UCL has been published to date. Podesta and colleagues²³ injected PRP into the elbow of 34 baseball players with MRI-confirmed partial UCL tear. The athletes then underwent a rehabilitation program, which limited stress across the UCL. Type 1A PRP was used (leukocyte-rich, unactivated, 5x or greater platelet concentration³³). Athletes were allowed to return to sport based on symptoms and examination findings. Eighty-eight percent returned to same level of play without complaints at average 70 week follow-up, and average return to play ranged from 10 to 15 weeks.²³ No specific data were given on the 16 pitchers in the group, but with such a high rate of return, PRP needs to be further evaluated in the treatment of UCL injuries.

Another recent study from Dugas and colleagues¹⁸ presented primary UCL repair using a tape augment (InternalBrace, Arthrex). Nine matched cadaver elbows underwent UCL sectioning and then either modified Jobe reconstruction or primary repair of the UCL with placement of the InternalBrace. The biomechanical data showed the repair with internal brace to have slightly less gap, more stiffness, and higher failure strength, although these findings were not statistically significant.¹⁸ This bone-preserving technique with less exposure and healing of the native ligament may be another step towards good results with a quicker return to throwing.

Conclusion

UCL injuries can be disabling in throwers. Reconstruction has afforded throwers a high rate of return to preinjury function or better, and several techniques have been presented that produce acceptable results. Overall complication rates range from 10% to 15%, and the majority of complications are transient ulnar neuropraxias. Orthobiologics and repair with augmentation have more recently offered additional options that may improve success of nonoperative treatment or allow less-invasive surgical treatment. Increased involvement in youth sports and early specialization is driving injury rates in young athletes. The orthopedic community must continue to look for better ways to prevent these injuries and investigate better methods to return athletes to high-level competition.

Am J Orthop. 2016;45(7):E534-E540. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

“Still Down: What to Do When Antidepressants Fail” by Dean F. MacKinnon, MD, is a compact little book that recently was released by Johns Hopkins University Press. The title, “Still Down,” says it all. At 152 pages, the book is short, but not because it isn’t jammed full of information, but because – like the title – the writing is succinct and straight to the point; there’s no flowery detail, and Dr. MacKinnon doesn’t parse words. He tells the reader up front what his mission is, how the book is organized, and who his audience is. He’s an organized writer who captures the reader while getting his point across.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has known Dr. MacKinnon for many years.

“Still Down: What to Do When Antidepressants Fail” by Dean F. MacKinnon, MD, is a compact little book that recently was released by Johns Hopkins University Press. The title, “Still Down,” says it all. At 152 pages, the book is short, but not because it isn’t jammed full of information, but because – like the title – the writing is succinct and straight to the point; there’s no flowery detail, and Dr. MacKinnon doesn’t parse words. He tells the reader up front what his mission is, how the book is organized, and who his audience is. He’s an organized writer who captures the reader while getting his point across.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has known Dr. MacKinnon for many years.

“Still Down: What to Do When Antidepressants Fail” by Dean F. MacKinnon, MD, is a compact little book that recently was released by Johns Hopkins University Press. The title, “Still Down,” says it all. At 152 pages, the book is short, but not because it isn’t jammed full of information, but because – like the title – the writing is succinct and straight to the point; there’s no flowery detail, and Dr. MacKinnon doesn’t parse words. He tells the reader up front what his mission is, how the book is organized, and who his audience is. He’s an organized writer who captures the reader while getting his point across.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has known Dr. MacKinnon for many years.

U.S.-based researchers have isolated replicative Zika virus RNA from the brain tissue of infants with microcephaly, and the placenta and fetal tissues from women suspected of being infected with Zika virus during pregnancy.

In a paper published online in Emerging Infectious Diseases, Julu Bhatnagar, PhD, of the Infectious Diseases Pathology Branch at the Center for Emerging and Zoonotic Infectious Diseases in Atlanta, and her coauthors reported a case series in 52 patients – 8 infants with microcephaly who died and 44 women thought to have been infected with Zika virus during pregnancy – using Zika virus reverse transcription PCR and in situ hybridization assay to detect the virus.

copyright Devonyu/Thinkstock

[email protected]

On Twitter @idpractitioner

U.S.-based researchers have isolated replicative Zika virus RNA from the brain tissue of infants with microcephaly, and the placenta and fetal tissues from women suspected of being infected with Zika virus during pregnancy.

In a paper published online in Emerging Infectious Diseases, Julu Bhatnagar, PhD, of the Infectious Diseases Pathology Branch at the Center for Emerging and Zoonotic Infectious Diseases in Atlanta, and her coauthors reported a case series in 52 patients – 8 infants with microcephaly who died and 44 women thought to have been infected with Zika virus during pregnancy – using Zika virus reverse transcription PCR and in situ hybridization assay to detect the virus.

copyright Devonyu/Thinkstock

[email protected]

On Twitter @idpractitioner

U.S.-based researchers have isolated replicative Zika virus RNA from the brain tissue of infants with microcephaly, and the placenta and fetal tissues from women suspected of being infected with Zika virus during pregnancy.

In a paper published online in Emerging Infectious Diseases, Julu Bhatnagar, PhD, of the Infectious Diseases Pathology Branch at the Center for Emerging and Zoonotic Infectious Diseases in Atlanta, and her coauthors reported a case series in 52 patients – 8 infants with microcephaly who died and 44 women thought to have been infected with Zika virus during pregnancy – using Zika virus reverse transcription PCR and in situ hybridization assay to detect the virus.

copyright Devonyu/Thinkstock

[email protected]

On Twitter @idpractitioner